The US Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif; Pfizer) for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML) who did not respond or were resistant to prior therapy.
The FDA granted expedited approval for enzalutamide (Xtandi; Medivation and Astellas Pharma US) on August 31, 2012. Enzalutamide was approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel.
On July 20, 2012, the FDA granted accelerated approval to carfilzomib injection (Kyprolis; Onyx Pharmaceuticals) for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and who have demonstrated disease progression on or within 60 days of the completion of their last therapy.
On August 3, 2012, the US Food and Drug Administration (FDA) approved ziv-aflibercept (Zaltrap, Sanofi US Inc) for use in combination with FOLFIRI (5-fluorouracil, leuco - vorin, and irinotecan) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing chemotherapy regimen. Ziv-aflibercept, which was previously known as aflibercept, is an angiogenesis inhibitor that inhibits the blood supply to tumors.
The FDA approved everolimus (Afinitor; Novartis Pharmaceuticals Corporation) for use in combination with exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer who experienced treatment failure with letrozole or anastrozole. The approval was granted on July 20, 2012.
To sign up for our newsletter or print publications, please enter your contact information below.
