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FDA APPROVES NEW DOSING FOR FASLODEX® (fulvestrant) INJECTION IN TREATMENT OF METASTATIC BREAST CANCER IN HR+ POSTMENOPAUSAL WOMEN
Approval based on Phase III study showing 500mg dose improved progression free survival over 250mg dose, with a comparable safety and tolerability profile
For immediate release: September 10, 2010
WILMINGTON, DE – AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.1 The FDA approval of FASLODEX 500mg was based on results from CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer), a Phase III study which demonstrated that FASLODEX 500mg significantly reduced the risk of disease progression in patients with metastatic breast cancer, when compared with the 250mg dose. Safety and tolerability profiles of both doses were comparable.2
“This approval is an important advancement for women with metastatic breast cancer, where the treatment approach is centered on delaying disease progression,” said Gershon Locker, M.D., Medical Director for AstraZeneca. “FASLODEX at 250mg has been an important treatment option for many women, and we now have data to show that the new 500mg dosing regimen can improve progression free survival compared with the 250mg dose.”
The recommended dose of FASLODEX 500mg should be administered intramuscularly into the buttocks as two 250mg injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter. A dose of 250mg is recommended in patients with moderate hepatic impairment.1
FASLODEX 500mg will be supplied as 2 x 250mg/5mL packaged together in early fourth quarter 2010. During this time, FASLODEX 250mg will still be available.
According to data from the U.S. National Cancer Institute, more than 207,000 American women will be diagnosed with breast cancer in 2010.3 pproximately 155,000 women in the United States are currently living with metastatic breast cancer, and this number is projected to increase to nearly 162,000 by the year 2011.4
The CONFIRM study, presented for the first time at the annual San Antonio Breast Cancer Symposium (SABCS) in December 2009, showed FASLODEX 500mg reduced the risk of disease progression (assessed as progression free survival) by 20 percent (HR 0.80; 95% CI 0.68-0.94, p=0.006) when compared with FASLODEX 250mg. FASLODEX 500mg significantly increased median progression free survival to 6.5 months vs. 5.4 months with 250mg (p=0.006).
Objective Response Rates calculated in patients with measurable disease was not significantly different between FASLODEX 500mg (13.8%) and 250mg (14.6%) (HR=0.94; 95% CI: 0.57-1.55) (p=0.795). Median overall survival was 25.1 months with FASLODEX 500mg and 22.8 months with 250mg (HR=0.84; 95% CI: 0.69-1.03) (p=0.091). At the time of analysis, overall survival was not statistically significant. A pre-planned second survival analysis will occur as data mature when approximately 75% of patients have had an event.
Important Safety Information About FASLODEX® (fulvestrant) Injection
FASLODEX is contraindicated in patients with known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema
have been reported in association with FASLODEX.
Because FASLODEX is administered intramuscularly, it should be used with caution in
patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants.
FASLODEX is metabolized primarily in the liver. A 250-mg dose is recommended in
patients with moderate hepatic impairment. FASLODEX has not been evaluated in
patients with severe hepatic impairment (Child-Pugh Class C).
Fetal harm can occur when administered to a pregnant woman. Women should be advised of the potential hazard to the fetus and to avoid becoming pregnant while receiving FASLODEX.
The most common, clinically significant adverse reactions occurring in ≥5% of patients
receiving FASLODEX were: injection site pain, nausea, bone pain, arthralgia, headache,
back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation.
Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX users and
were non dose-dependent.
Approved Use For FASLODEX
FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast
cancer in postmenopausal women with disease progression following antiestrogen
therapy.
Please see full Prescribing Information. If you have any questions concerning FASLODEX, please contact AstraZeneca Information Center at 1-800-236-9933, open Monday to Friday from 8 AM to 6 PM, excluding holidays.
About CONFIRM
CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer) was a Phase III, randomized, double-blind, parallel-group, multi-center trial comparing fulvestrant 500 mg (n=362) and 250 mg (n=374) in postmenopausal women with estrogen receptor-positive advanced breast cancer, who progressed or recurred following one prior endocrine therapy (antiestrogen or aromatase inhibitor). Eligible patients were randomized 1:1 to fulvestrant 500mg or 250mg, and assessed for tumor progression every 12 weeks. The primary objective was to compare the efficacy of both treatment groups in terms of progression free survival. Secondary objectives included: objective response rate (ORR), clinical benefit rate (CBR), duration of clinical benefit (DoCB), overall survival and quality of life (QoL). Safety and tolerability were also assessed.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business.
For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
CONTACTS:
Media Inquiries:
Blair Hains (302) 885-1813, blair.hains@astrazeneca.com
Rachelle Benson (302) 885-5853, rachelle.benson@astrazeneca.com
- ENDS -
1FASLODEX Prescribing Information.
2Di Leo A, Jerusalem G, Petruzelka L et al. CONFIRM: Phase III, randomized, parallel-group trial comparing fulvestrant 250 mg vs fulvestrant 500 mg in postmenopausal women with oestrogen receptor-positive advanced breast cancer. San Antonio Breast Cancer Symposium 2009. Abstract 25.
3National Cancer Institute. Surveillance Epidemiology and End Results cancer statistics. Web site: http://seer.cancer.gov/statfacts/html/breast.html. Accessed August 10, 2010.
4Data on File, 266478. AZPLP. Wilmington, DE.
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Merck Announces Receipt of J-Code Designation from Centers for Medicare & Medicaid Services for TEMODAR® (temozolomide) for Injection
WHITEHOUSE STATION, NJ -- January 8, 2010 – Merck announced today that the Centers for Medicare & Medicaid Services (CMS), under the Medicare Part B benefit, has assigned a product-specific billing code, or J-code, for TEMODAR® (temozolomide) for Injection. The J-code, J9328 (injection, temozolomide, per 1 mg), is effective as of January 1, 2010.
The Healthcare Common Procedure Coding System National Panel reviewed Merck’s application and assigned the product-specific J-code for use by payers. The HCPCS National Panel is made up of members of the private insurance industry, Medicaid, and Medicare. TEMODAR is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. The IV formulation is supplied in single-use glass vials containing 100 mg temozolomide. TEMODAR given as an intravenous infusion over 90 minutes is bioequivalent to the capsule formulation.
TEMODAR for Injection has a separate J-code from TEMODAR Capsules.
About TEMODAR (temozolomide) for Injection
TEMODAR is contraindicated in patients who have a history of hypersensitivity (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and Stevens-Johnson syndrome) to any of its components, or to DTIC.
Patients treated with TEMODAR may experience myelosuppression including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome.
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In some cases, exposure to concomitant medications associated with aplastic anemia including carbamazepine, phenytoin, and sulfamethoxazole/ trimethoprim complicates assessment. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Causes of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have also been observed.
Prophylaxis against Pneumocystis carinii pneumonia is required for all patients receiving concomitant TEMODAR and radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. However, all patients receiving temozolomide, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of regimen.
TEMODAR can cause fetal harm when administered to a pregnant woman. In nursing women, a decision should be made whether to discontinue nursing or to discontinue TEMODAR, taking into account the importance of the drug to the mother. The safety and effectiveness of TEMODAR in children have not been established.
As bioequivalence between TEMODAR Capsules and TEMODAR for Injection has been established only when TEMODAR for Injection was given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing. Additionally, the possibility of an increase in infusion-related adverse reactions cannot be ruled out.
TEMODAR Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes.
Caution should be exercised when administered to those with severe hepatic or renal impairment.
The adverse event profile was similar in patients <65 years of age and those ≥65 years.
When laboratory abnormalities and adverse events were combined, Grade 3 or 4 neutropenia occurred in 8% and Grade 3 or 4 platelet abnormalities, including thrombocytopenia events, occurred in 14% of patients treated with temozolomide.
Side effects in studies with the intravenous formulation that were not reported in TEMODAR Capsule studies were: pain, irritation, pruritus, warmth, swelling, and erythema at infusion site as well as the following adverse reactions: petechiae and hematoma. Full prescribing information for TEMODAR can be found at www.temodar.com.
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About Merck
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com
Forward Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
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Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be
found in Merck’s 2008 Annual Report on Form 10-K, Schering-Plough’s Quarterly Report on Form 10-Q for the quarterly period ended Sept. 30, 2009, the proxy statement filed by Merck on
June 25, 2009 and each company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). |
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On February 4, 2009, DrugDex updated its Abraxane monograph to include first-line combination treatment of NSCLC. The language from the DrugDex monograph appears below.
4.5.E Non-small cell lung cancer, Advanced or metastatic, first-line treatment, in combination with carboplatin and bevacizumab
1) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference: RECOMMENDATION AND EVIDENCE RATINGS
2) Summary:
In an open-label, phase 2 study presented in abstract form and as a presentation (n=50), 31.3% of patients with advanced non-small-cell lung cancer (NSCLC) achieved a partial response following first-line therapy with nanoparticle albumin-bound paclitaxel, carboplatin, and bevacizumab.(Reynolds et al, 2007; Reynoldset al,null).
Copies of the updated Abraxane monograph are available at Abraxis Oncology’s ARC of Support – that number is (800) 564-0216, Option 3. Representatives are available from 8 AM to 8 PM, Monday to Friday.
Please let me know if I may supply any additional information.
Regards,
Kristinna
West Regional Reimbursement Manager
Abraxis Oncology, a Division of Abraxis BioScience, Inc.
Phone: 619/434-4640
Mobile phone: 619/929-4539
Fax: 619/434-4641
ktiong@abraxisbio.com |
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Click here for pdf version
FDA Grants Lilly's ALIMTA(R) (Pemetrexed for Injection) Third U.S. Approval
First-Line Chemotherapy Regimen Showed Clinically Relevant Survival Differences in Specific Histology
Types of Advanced Non-Small Cell Lung Cancer
INDIANAPOLIS, Sept 29, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Eli Lilly and Company (NYSE: LLY)
announced today it received approval from the U.S. Food and Drug Administration (FDA) for the use of ALIMTA(R)
(pemetrexed for injection), in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small
cell lung cancer (NSCLC), for patients with nonsquamous histology. ALIMTA is not indicated for treatment of patients with
squamous cell non-small cell lung cancer. NSCLC is the most common form of lung cancer, resulting in more than 180,000 new
cases in the U.S. each year.(1,2)
NSCLC is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology
includes adenocarcinoma, large cell carcinoma and all other histologies except squamous cell carcinoma.
This marks the third U.S. indication for ALIMTA. In 2004, ALIMTA received consecutive approvals: first in combination with
cisplatin as a treatment for patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise
not candidates for curative surgery, and then as a single agent for the second-line treatment of patients with locally-advanced
or metastatic NSCLC after prior chemotherapy treatment.(3)
The ALIMTA approval in first-line advanced NSCLC for nonsquamous cell histology is based on a Phase III, open-label
randomized study (1725 patients) that evaluated ALIMTA plus cisplatin (AC arm) versus GEMZAR(R) (gemcitabine HCl for
injection) plus cisplatin (GC arm). The median survival was 10.3 months in the AC arm and 10.3 months in the GC arm
[adjusted hazard ratio 0.94 (95% CI: 0.84, 1.05)]. The median progression-free survival was 4.8 and 5.1 months for the AC and
GC arms, respectively [adjusted hazard ratio 1.04 (95% CI: 0.94, 1.15)]. The overall response rates were 27.1% and 24.7% for
the AC and GC arms, respectively.
In a pre-specified analysis, the impact of NSCLC histology on overall survival was examined. Clinically relevant differences in
survival according to histology were observed. In the nonsquamous cell NSCLC subgroup, the median survival was 11.0 and
10.1 months in the AC and GC groups, respectively [unadjusted hazard ratio 0.84 (95% CI: 0.74, 0.96)]. However, in the
squamous cell histology subgroup, the median survival was 9.4 versus 10.8 months in the AC and GC groups, respectively
[unadjusted hazard ratio 1.22 (95% CI: 0.99, 1.50)].(4) This unfavorable effect on overall survival associated with squamous
cell histology observed with pemetrexed was also noted in a retrospective analysis of the single-agent trial of pemetrexed
versus docetaxel in patients with stage III/IV NSCLC after prior chemotherapy.(5)
Patients treated with the ALIMTA regimen had less hematologic toxicity, fewer blood transfusions and decreased use of growth
factors compared to those treated with the GEMZAR regimen. The most common adverse reactions (incidence greater than or
equal to 20%) for ALIMTA in combination with cisplatin included vomiting, neutropenia, leukopenia, anemia,
stomatitis/pharyngitis, thrombocytopenia and constipation.
Based on the same data, the FDA also approved a change to the second-line indication. ALIMTA is indicated as a single agent
for the treatment of patients with locally-advanced or metastic nonsquamous non-small cell lung cancer after prior
chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.
For full prescribing and safety information about ALIMTA, visit www.ALIMTA.com.
Notes to Editor
About Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer and represents 85 to 90 percent of all lung cancers.(6) NSCLC has five-tier
staging, starting at 0 and rising to the severity of stage IV.(7) NSCLC can spread through the lymphatic system, penetrating the
chest lining, ribs, and the nerves and blood vessels that lead to the arm. The liver, bones and brain are potential targets if the
cancerous cells enter the bloodstream.
According to the World Health Organization (WHO) Cancer Report, lung cancer is the world's most common cancer and the
leading cause of cancer death for men and women. More than 1 million people die from lung cancer each year.(8)
NSCLC is defined as a group of histologies, that is, tumor types differentiated by cellular structure. The most common NSCLC
histology types are squamous carcinoma, adenocarcinoma and large cell carcinoma.(9)
About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology has been dedicated to delivering innovative solutions that improve the care of
people living with cancer. Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment
approaches. Our quest is to develop a broad portfolio of tailored therapies that accelerate the pace and progress of cancer
care. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of
the world's most urgent medical needs.
P-LLY
ALIMTA(R) (pemetrexed for injection), Lilly
GEMZAR(R) (gemcitabine HCl for injection), Lilly
This press release contains forward-looking statements about the potential of ALIMTA and GEMZAR for the treatment of nonsmall
cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development,
there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is
no guarantee that the products will receive additional regulatory approvals. There is also no guarantee that the products will
continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Important Safety Information for ALIMTA
ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced
nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a
different type of NSCLC called squamous cell.
ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous nonsmall
cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who
have a different type of NSCLC called squamous cell.
ALIMTA is a treatment for Malignant Pleural Mesothelioma (MPM), which is a cancer that affects the inside lining of the chest
cavity. ALIMTA is given with cisplatin, another anti-cancer medicine (chemotherapy) when surgery is not an option.
Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.
ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not
receive it. If you think you are pregnant, are planning to be pregnant, or are nursing, please tell your healthcare team. ALIMTA
may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent
pregnancy while you are being treated with ALIMTA.
If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may
not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow
function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your
chances of harmful side effects.
Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin
reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory
drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are
low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting,
and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.
Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean
you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that
doesn't go away, be sure to talk with your healthcare professional.
You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA
or delay your treatment based on the results of your blood test and on your general condition.
For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the complete
Prescribing Information at www.ALIMTA.com, or call 1-800-545-5979.
Important Safety Information for GEMZAR
GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with
locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer for whom
surgery is not possible.
Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy.
GEMZAR may not be appropriate for some patients. If you are allergic to GEMZAR, tell your doctor you should not receive it.
GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR
treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are
planning to be pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.
If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be
right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including
prescription and non-prescription medicines, vitamins, or herbal supplements.
There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red
blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea;
rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects
of GEMZAR. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare
professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an
infection.
You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of
GEMZAR or delay your treatment based on the results of your blood test and on your general condition.
For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the complete
Prescribing Information at www.GEMZAR.com, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-
800-FDA-1088.
(1) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non- Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21,
2008).
(2) American Cancer Society, "What Are the Key Statistics About Lung Cancer?," October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statisti cs_About_Lung_Cancer_15.asp?rnav=cri,
(September 19, 2008).
(3) NOTE: The 2nd-line NSCLC indication was approved under 21 CFR 314.500 et seq (Subpart H - Accelerated Approval of
New Drugs for Serious or Life-Threatening Illnesses) using a surrogate endpoint.
(4) Scagliotti G, Vittorio P, et al. Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in
Chemotherapy-Naive Patients With Advanced-Stage Non-Small-Cell Lung Cancer; J Clin Oncol 2008 26: 3543- 3551.
(5) Peterson P, Park K, et al. Is pemetrexed more effective in patients with non-squamous histology? A retrospective analysis of
a phase III trial of pemetrexed vs docetaxel in previously treated patients with advanced nonsmall cell lung cancer (NSCLC).
Abstract P#6521, The European Cancer Conference 2007 (ECCO 14). European Journal of Cancer Supplements, Vol 5 No 4,
Page 363.
(6) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non- Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21,
2008).
(7) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?" October 15, 2007, American Cancer Society,
www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non- Small_Cell_Lung_Cancer_Staged.asp?rnav=cri, (February 21,
2008).
(8) World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health,
2003, http://www.who.int/gender/documents/en/lungcancerlow.pdf.
(9) National Cancer Institute, "Non-Small Cell Lung Cancer Treatment (PDQ(R)) Health Professional Version," December 14,
2007, National Cancer Institute, www.cancer.gov/cancertopics/pdq/treatment/non-small-cell- ng/HealthProfessional/page2,
(February 14, 2008).
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
Copyright (C) 2008 PR Newswire. All rights reserved
News Provided by COMTEX |
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Astra Zeneca’s Office Resource Series modules can be scheduled on an as needed basis.
To request a program, please contact your local AstraZeneca Pharmaceutical Sales Specialists.
Click HERE for more info
Program Topics:
Module A: Commercial Insurance Trends & Oncology Practice Considerations
Module B: Preparing for Quality of Care Initiatives: Pay for Performance
Module C: Oncology Coding & Reimbursement in the Physician Office Setting
Module D: Oncology-Related Reimbursement Changes in the Physician Office
Module E: Hospital Reimbursement Overview - Oncology Services
Module F: Medicare Part D Prescription Drug Benefit
Module G: Mini Modules
1. Preparing for New quality of Care Initiative: Pay for Performance (P4P)
2. Consumer-Driven Health Plans
3. Medicare Overview
4. Oncology Related Reimbursement Changes in the Physician Office
5. Medicare Part D Prescription Drug Benefit
6. Medicare Contracting Reform
7. Competitive Acquisition Program (CAP)
8. Electronic Health Records (EHR): Considerations for Oncology
9. Commercial Insurance Trends & Oncology Practice Considerations
10. Specialty Pharmacy Programs (SPP)
11. Preparing for Medicare's Physician Quality Reporting Initiative (PQRI) |
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Celgene Corporation is pleased to announce that VIDAZA® (azacitidine for injection) has received approval from the US Food and Drug Administration to include survival data for patients with higher-risk myelodysplastic syndromes (MDS) in its prescribing information. A PDF file of the updated Vidaza prescribing information is attached to this message. For more information, please visit www.vidaza.com.
PLEASE NOTE:
VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
IMPORTANT SAFETY INFORMATION:
- VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors
- In Studies 1 and 2, the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%)
- In Study 4, the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%), and febrile neutropenia (12.6%)
- Because treatment with VIDAZA is associated with anemia, neutropenia, and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle
- Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function
- VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA
- Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
I you have any questions regardin this message, please contact:
George K. Malouly
National Account Management
Celgene Corporation
310.859.0175 office
gmalouly@celgene.com
http://www.celgene.com |
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© 2008 Medical Oncology Association of Southern California
P.O. Box 161 •
Upland, CA 91785
Phone: (909) 985-9061 •
Fax: (909) 985-8581 • email: moasc@moasc.org
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