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.
Category: FDA Approvals
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.