The FDA on June 8, 2012 approved PERJETA® injection for use in combination with HERCEPTIN® (Trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. PERJETA® is a product of Genentech, Inc.
Category: FDA Approvals
ERBITUX® (Cetuximab)
The FDA on July 9, 2012 granted approval to ERBITUX® for use in combination with FOLFIRI (CAMPTOSAR® [Irinotecan], 5-fluorouracil, leucovorin) for first-line treatment of patients with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX® is a product of Eli Lilly and Co.
KYPROLIS® (Carfilzomib injection)
The FDA on July 20, 2012 granted accelerated approval to KYPROLIS® for the treatment of patients with multiple myeloma who have received at least two prior therapies, including VELCADE® (Bortezomib) and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy. KYPROLIS® is a product of Onyx Pharmaceuticals.
AFINITOR® (Everolimus tablets)
The FDA on July 20, 2012 approved AFINITOR® for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with FEMARA® (Letrozole) or ARIMIDEX® (Anastrozole). AFINITOR® is a product of Novartis Pharmaceuticals Corporation.
SYNRIBO® (Omacetaxine mepesuccinate)
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.
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.