FDA Grants Accelerated Approval to Ponatinib
FDA Updates; 12/14/2012
The U.S. Food and Drug Administration granted accelerated approval to ponatinib (Iclusig™ tablets, ARIAD Pharmaceuticals, Inc.) for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
FDA Approves Expanded Indication for Abiraterone Acetate
FDA Updates; 12/10/2012
The U.S. Food and Drug Administration approved an expanded indication for abiraterone acetate (Zytiga® Tablets, Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
FDA Approves Cabozantinib
FDA Updates; 11/29/2012
The U.S. Food and Drug Administration approved cabozantinib (COMETRIQ™ capsules, Exelixis, Inc), for the treatment of patients with progressive metastatic medullary thyroid cancer (MTC).
FDA Grants Approval to Omacetaxine Mepesuccinate
FDA Updates; 10/26/2012
The U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate, (SYNRIBO® for Injection, for subcutaneous use, Teva Pharmaceutical Industries Ltd.), 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).
FDA Approves Infusion for Rituximab
FDA Updates; 10/19/2012
The U.S. Food and Drug Administration approved a 90-minute infusion for rituximab (Rituxan® Injection, Genentech, Inc.) 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.
FDA Expands Labeling of Pemetrexed
FDA Updates; 10/17/2012
The U.S. Food and Drug Administration expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (ALIMTA®, Eli Lilly and Company) 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.
FDA Approves Abraxane® Protein-Bound Particles for Injectable Suspension
FDA Updates; 10/11/2012
The US Food and Drug Administration approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (ABRAXANE® for Injectable Suspension; Abraxis Bioscience a wholly owned subsidiary of Celgene Corporation) for use in combination with 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.
FDA Approves Regorafenib
FDA Updates; 09/27/2012
The U.S. Food and Drug Administration approved regorafenib (Stivarga® tablets, Bayer HealthCare Pharmaceuticals, Inc.), for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
FDA Approves Bosutinib Tablets for Adult Patients with CML
FDA Updates; 09/04/2012
The U.S. Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif®, Pfizer, Inc.) 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.
FDA Approved Enzalutamide (XTANDI® Capsules)
FDA Updates; 08/31/2012
The U.S. Food and Drug Administration (FDA) approved enzalutamide (XTANDI® Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.