FDA Updates

The US Food and Drug Administration (FDA) has approved omacetaxine mepesuccinate subcutaneous injection (Synribo, Teva Pharmaceutical Industries) for the treatment of adult patients with chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs). Approval for omacetaxine mepesuccinate was granted on October 26, 2012.
The US Food and Drug Administration (FDA) approved regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) 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. Regorafenib approval was granted on September 27, 2012.
On October 4, 2012, the FDA and the US Centers for Disease Control and Prevention (CDC) recommended that all healthcare professionals cease use and remove from pharmaceutical inventory any product produced by the New England Com­pounding Center (NECC).

On July 20, 2012, the FDA granted accelerated approval to carfilzomib injection (Kyprolis; Onyx Pharmaceuticals) for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortez­omib and an immunomodulatory agent, and who have demonstrated disease progression on or within 60 days of the completion of their last therapy.

The FDA granted expedited approval for enzalutamide (Xtandi; Medivation and Astellas Pharma US) on August 31, 2012. Enzalutamide was approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel.

The US Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif; Pfizer) for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML) who did not respond or were resistant to prior therapy.

The FDA approved Erivedge (vismodegib; Genentech) capsule for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred after surgery or who are not candidates for surgery, and who are not candidates for radiation. Basal cell carcinoma is the most common type of skin cancer, and vismodegib is the first drug approved by the FDA for metastatic basal cell carcinoma.

Picato (ingenol mebutate; LEO Pharma) gel was approved in January by the FDA for the topical treatment of actinic keratosis (AK) on the face, scalp, trunk, and extremities. AK is a precancerous condition caused by cumulative sun exposure that has the potential to progress to squamous cell carcinoma, which is the second most common type of skin cancer. AK is a dry, scaly, rough-textured patch or lesion that forms on the outermost layer of the skin after cumulative exposure to ultraviolet light, including sunlight.

The FDA revoked approval of the breast cancer indication for Avastin (bevacizumab; Genentech), ruling that the drug has not been proved to be safe and effective for that use. Bevacizumab remains on the market as approved for use for certain types of other cancers, including colon, kidney, lung, and brain (glioblastoma multiforme) cancer. Bevacizumab had received accelerated approval for the breast cancer indication in 2008; however, the FDA’s Oncologic Drugs Advisory Committee later recommended this approval be withdrawn.

The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) to increase bone mass in patients at high risk for fracture receiving androgen- deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. This monoclonal antibody that binds to RANKL was approved based on results of 2 randomized, double-blind, placebo-controlled trials. One trial randomized 1468 men with prostate cancer.

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