Recent FDA Updates

TON - February 2012 VOL 5, No 1 — February 29, 2012

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.

Vismodegib inhibits the hedgehog pathway, a channel used by cells to communicate. Malfunctions in the hedgehog pathway are thought to play a role in several types of cancer, and this pathway is a focus of research. The hedgehog pathway is crucial to embryonic development.

The most common adverse reactions (≥10%) for vismo­degib were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia. Three of 10 premenopausal women developed amenorrhea in clinical trials. Vismodegib approval carries a black box warning for the risk of fetal death or severe birth defects.

Ingenol Mebutate Gel Approved for Actinic Keratosis
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. Ingenol mebutate 0.015% gel is used once daily on the face and scalp for 3 consecutive days, and ingenol mebutate 0.05% gel is used once daily on the trunk and extremities for 2 consecutive days.

In four phase 3 clinical studies of more than 1000 patients with AK, a higher proportion of those treated with ingenol mebutate gel (n=503) saw complete clearance of AKs in the field of treatment compared with placebo (n=502). The most common adverse events were local skin reactions, including erythema, flaking/scaling, crusting, and swelling. Pain, pruritus, and infection at the application site, as well as periorbital edema and headache, were other adverse events that occurred in ≥2% of individuals treated with ingenol mebutate gel.

Bevacizumab Approval for Breast Cancer Revoked
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. Bevacizumab’s manufacturer filed an appeal, and the FDA held a 2-day public hearing on the issue in June 2011. The FDA issued the decision to revoke the breast cancer indication for bevacizumab on November 18, 2011.

The Oncology Nurse-APN/PA will address the implications of the FDA’s decision in an upcoming issue.

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