ICLUSIG® (Ponatinib): The FDA on December 17, 2012 granted accelerated approval to ICLUSIG® 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. ICLUSIG® is available as oral tablets and is a product of ARIAD Pharmaceuticals, Inc.
Category: FDA Approvals
ZYTIGA® (Abiraterone)
The FDA on December 10, 2012 approved an expanded indication for ZYTIGA® in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. ZYTIGA® tablets are a product of Janssen Biotech, Inc.
COMETRIQ® (Cabozantinib)
The FDA on November 29, 2012 approved COMETRIQ® for the treatment of patients with progressive metastatic medullary thyroid cancer (MTC). COMETRIQ® is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor 2. COMETRIQ® is available in capsule form and is a product of Exelixis, Inc.
VORAXAZE® (Glucarpidase)
The FDA on January 17, 2012 approved VORAXAZE® for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function. VORAXAZE® is a product of BTG International Inc.
ERIVEDGE® (Vismodegib)
The FDA on January 30, 2012 approved ERIVEDGE® for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. ERIVEDGE® is a product of Genentech, Inc.
GLEEVEC® (Imatinib)
The FDA on January 31, 2012 granted regular approval for GLEEVEC® (Imatinib mesylate) for the adjuvant treatment of adult patients for a period of 36 months following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST). GLEEVEC® is a product of Novartis Pharmaceuticals.
AFINITOR® (Everolimus tablets)
The FDA on April 26, 2012 granted accelerated approval to AFINITOR® for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex (TSC), who do not require immediate surgery. AFINITOR® is a product of Novartis Pharmaceuticals.
VOTRIENT® (Pazopanib tablets)
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.
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.