The FDA on October 26, 2012 granted accelerated approval to SYNRIBO® for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). SYNRIBO® is administered as a subcutaneous injection and is a product of Teva Pharmaceutical Industries Ltd.
Month: November 2012
RITUXAN® (Rituximab)
The FDA on October 19, 2012 approved a 90-minute infusion for RITUXAN® (Rituximab) starting at Cycle 2 for patients with non-Hodgkin’s lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during Cycle 1. Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (>5000/mcL) are not recommended to receive the faster infusion. RITUXAN® is a product of Genentech, Inc.
ALIMTA® (Pemetrexed)
> The FDA on October 17, 2012 expanded the labeling for ALIMTA® to include the results of an additional trial evaluating the safety and efficacy of ALIMTA®) for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer followed by pemetrexed maintenance in patients whose disease has not progressed after four cycles of platinum and pemetrexed as first-line chemotherapy. ALIMTA® is a product of Eli Lilly and Company.
ABRAXANE® (Paclitaxel albumin-bound particles)
The FDA on October 11, 2012 approved ABRAXANE® (Paclitaxel albumin-bound particles) for use in combination with PARAPLATIN® (Carboplatin) for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for curative surgery or radiation therapy. ABRAXANE® is an injectable suspension and is a product of Celgene Corporation.
STIVARGA® (Regorafenib)
The FDA on September 27, 2012 approved STIVARGA® (Regorafenib) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, ELOXATIN® (Oxaliplatin)-, and CAMPTOSAR® (Irinotecan)-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. STIVARGA® tablets are a product of Bayer HealthCare Pharmaceuticals, Inc.
BOSULIF® (Bosutinib)
The FDA on September 4, 2012 approved BOSULIF® (Bosutinib) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy. BOSULIF® tablets are a product of Pfizer, Inc.
XTANDI® (Enzalutamide)
The FDA on August 31, 2012 approved XTANDI® (Enzalutamide) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI® capsules are a product of Medivation, Inc. and Astellas Pharma US, Inc.
AFINITOR® (Everolimus)
The FDA on August 30, 2012 granted accelerated approval for AFINITOR® (Everolimus) for the treatment of pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. AFINITOR® tablets for oral suspension (AFINITOR® Disperz) is a product of Novartis Pharmaceuticals Corp.
MARQIBO® (vinCRIStine sulfate LIPOSOME injection)
The FDA on August 9, 2012 granted accelerated approval for MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. MARQIBO® is a product of Talon Therapeutics, Inc.
ZALTRAP® (Ziv-aflibercept injection)
The FDA on August 3, 2012 approved ZALTRAP® (Ziv-aflibercept injection), for use in combination with 5-fluorouracil, leucovorin, CAMPTOSAR® (Irinotecan) (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin containing regimen. ZALTRAP® is a product of Sanofi U.S., Inc.