Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves First Treatment for Rare Skin Cancer

FDA news release; 2017 Mar 23

The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of metastatic Merkel cell carcinoma (MCC).

Indications: Bavencio is a programmed death ligand-1 blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic MCC.

Dosage and administration: Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.

Efficacy and safety: Approval is based on data from a single-arm trial of 88 patients with metastatic MCC who received Bavencio. One-third experienced complete or partial shrinkage of their tumors. The response lasted for more than 6 months in 86% percent of responding patients, and more than a year in 45%.

Side effects/risks: The most common adverse reactions are fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema.


FDA approves first treatment for rare form of skin cancer. [news release]. Silver Spring, MD: FDA March 23, 2017. Accessed March 31, 2017.

Bavencio [package insert]. Rockland, MA: EMD Serono, Inc. 2017. Accessed March 31, 2017.

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Must Reads in FDA Actions

Varubi Approved for Delayed Nausea and Vomiting, Tesaro news release; 2017 Oct 25

FDA Approves Keytruda for Advanced Gastric Ca, Merck news release; 2017 Sep 22

FDA Approves Opdivo for Hepatocellular Carcinoma, Bristol-Myers Squibb news release; 2017 Sep 22

New Indication for Somatuline Depot, Ipsen package insert; 2017 Sep

Verzenio Approved for Certain Breast Cancers, FDA news release; 2017 Sep 28