FDA Approvals, News & Updates

On August 3, 2012, the US Food and Drug Administration (FDA) approved ziv-aflibercept (Zaltrap, Sanofi US Inc) for use in combination with FOLFIRI (5-fluorouracil, leuco - vorin, and irinotecan) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing chemotherapy regimen. Ziv-aflibercept, which was previously known as aflibercept, is an angiogenesis inhibitor that inhibits the blood supply to tumors.

The FDA approved everolimus (Afinitor; Novartis Pharmaceuticals Corporation) for use in combination with exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer who experienced treatment failure with letrozole or anastrozole. The approval was granted on July 20, 2012.

As many as 1 in 5 cancer patients may experience obstacles in their care, according to a new study published in the Journal of Clinical Oncology. These obstacles include communication issues between patients and their healthcare providers, along with traditional medical errors.

Vismodegib Capsule Approved for Metastatic Basal Cell Carcinoma
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.

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.

The FDA has granted 510k marketing clearance to an invitro diagnostic assay (NADiA ProsVue, Iris International) for determining rate of change of serum total prostate-specific antigen over a period of time. A slope of 3 assays is indicated for use as a prognostic marker in conjunction with clinical evaluation to aid in identifying those patients at reduced risk for recurrence of prostate cancer for the 8-year period following prostatectomy.

The FDA issued a statement warning physicians of changes in the package insert for bevacizumab (Avastin, Genentech) regarding newly identified risks.

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