The FDA on April 26, 2012 approved VOTRIENT® for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. VOTRIENT® is a product of GlaxoSmithKline.
Category: FDA Approvals
PERJETA® (Pertuzumab)
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.
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.