FDA Drug Approvals, January–March 2012
- Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Accelerated approval for this indication was granted in December 2008.
- Vismodegib (Erivedge) capsules approved for the treatment of metastatic basal cell carcinoma or locally advanced basal cell carcinoma in patients whose disease has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
- Axitinib tablets (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.
- Glucarpidase injection (Voraxaze) for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function.
For more information, visit fda.gov.