2012 In Review: Oncology Drugs/Indications Newly Approved by FDA


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At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2012.

Cabozantinib (Cometriq) for the treatment of progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor 2.  November 29, 2012

Omacetaxine mepesuccinate (Synribo) for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors. October 26, 2012

Rituximab (Rituxan) 90-minute infusion starting at cycle 2 for patients with non-Hodgkin lymphoma who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1. October 19, 2012

Pemetrexed (Alimta) labeling was expanded to include the results of an additional trial evaluating the drug’s safety and efficacy 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. October 17, 2012

Paclitaxel, albumin-bound (Abraxane) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer who are not candidates for curative surgery or radiation therapy. October 11, 2012

Regorafenib (Stivarga) for the treatment of patients with metastatic colorectal cancer 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. September 27, 2012

Bosutinib (Bosulif) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive chronic myelogenous leukemia in adult patients with resistance or intolerance to prior therapy. September 4, 2012

Enzalutamide (Xtandi) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. August 31, 2012

Everolimus (Afinitor) received accelerated approval for the treatment of pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected. August 30, 2012

Vincristine sulfate liposome injection (Marqibo) received accelerated approval for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. August 9, 2012

Ziv-aflibercept (Zaltrap) for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin (Eloxatin) containing regimen. August 3, 2012

Everolimus (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 letrozole (Femara) or anastrozole (Arimidex). July 20, 2012

Carfilzomib (Kyprolis) received accelerated approval for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib (Velcade) and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy. July 20, 2012

Cetuximab (Erbitux) for use in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of patients with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests for this use. FDA also approved the Therascreen KRAS RGQ PCR Kit (Qiagen) concurrent with this cetuximab approval. July 9, 2012

Pertuzumab (Perjeta) for use in combination with 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. June 8, 2012

Pazopanib (Votrient) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy. April 26, 2012 

Everolimus (Afinitor) received accelerated approval for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex, who do not require immediate surgery. April 26, 2012

Imatinib mesylate (Gleevec) received regular approval for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors. Accelerated approval for this indication was granted in December 2008. Labeling is also revised to include the results of a randomized trial demonstrating that recurrence-free survival and overall survival were improved by continuing adjuvant imatinib therapy to 36 months. January 31, 2012

Vismodegib (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. January 30, 2012

Axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. January 27, 2012

Glucarpidase  (Voraxaze) for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function. January 17, 2012 ■



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