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Oncologic Drugs Advisory Committee (ODAC) Materials

March 13, 2008

Ortho Biotech Food and Drug Administration
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Latest Press Releases
03/13/2008    Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
03/11/2008    Totality of Available Data Reaffirms PROCRIT® (Epoetin alfa) Safe and Effective When Used Appropriately As Labeled to Treat Chemotherapy-Induced Anemia
03/07/2008    Ortho Biotech Modifies Prescribing Information for PROCRIT® (Epoetin alfa)
02/26/2008    Ortho Biotech Statement on JAMA Publication Regarding Erythropoiesis-Stimulating Agents
02/06/2008    Call for Entries - 2008 CURE Extraordinary Healer Award for Oncology Nursing
02/01/2008    OBSERVATIONAL DATA SHOW TRANSFUSION PATTERNS IN CHEMOTHERAPY-INDUCED ANEMIA PATIENTS RECEIVING ERYTHROPOIESIS-STIMULATING AGENTS
12/11/2007    MODELING SIMULATION PREDICTS POTENTIAL NEGATIVE IMPACT ON U.S. BLOOD SUPPLY IF ESA USE LIMITED FOR CHEMOTHERAPY-INDUCED ANEMIA
12/07/2007    Twelve DOXIL® Clinical Studies to Be Presented at American Society of Hematology Annual Meeting
12/06/2007    PROCRIT® (Epoetin alfa) DATA TO BE PRESENTED AT AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING
12/04/2007    Updated Analysis of 2001 Epoetin Alfa Study Posted
11/08/2007    Ortho Biotech Modifies Prescribing Information for PROCRIT® (Epoetin alfa)
11/08/2007    ORTHO BIOTECH TO SUBMIT OFFICIAL REQUEST FOR RECONSIDERATION TO CMS REGARDING ESA COVERAGE POLICY
11/01/2007    PROCRIT® (Epoetin Alfa) DATA TO BE PRESENTED AT AMERICAN SOCIETY OF NEPHROLOGY ANNUAL MEETING
09/11/2007    ORTHO BIOTECH SUPPORTS FDA ADVISORY COMMITTEES' RECOMMENDATIONSON USE OF ESAs IN CHRONIC RENAL FAILURE PATIENTS
09/11/2007    Ortho Biotech Reiterates Confidence in PROCRIT® (Epoetin alfa) Safety and Efficacy When Used According to Label
09/05/2007    Results from Study Evaluating PROCRIT® in Intensive Care Unit Patients Published in New England Journal of Medicine
06/13/2007    CMS COVERAGE PROPOSAL FOR ERYTHROPOIESIS-STIMULATING AGENTS (ESAs) JEOPARDIZES CANCER CLINICAL PRACTICE AND PATIENT ACCESS
05/21/2007    U.S. FDA Approves VELCADE® + DOXIL® Combination for Treatment of Relapsed/Refractory Multiple Myeloma
03/07/2007    Ortho Biotech Revises Prescribing Information for PROCRIT®(Epoetin alfa)
03/07/2007    Former U.S. Surgeon General Joycelyn Elders Urges Americans to Know the Risk Factors and Get Screened for Chronic Kidney Disease on World Kidney Day
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Boxed WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:
  • ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of >= 12 g/dL.
  • The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
  • To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
  • Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • Discontinue following the completion of a chemotherapy course.
Perisurgery: PROCRIT® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

(See WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, WARNINGS: Increased Mortality and/or Tumor Progression, and DOSAGE AND ADMINISTRATION.)

Please see Full Prescribing Information, including Boxed WARNINGS for more details.

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