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.

This Week's Must Reads

How do you pronounce that drug name?, Frank D. JAMA Intern Med. 2018;178(3):319-320. doi:10.1001/jamainternmed.2017.7898

'Glass ceiling' extends to biomedical industry payments, Tringale K and Hattangadi-Gluth J. JAMA Intern Med. 2018;178(3):421-423. doi:10.1001/jamainternmed.2017.7445

Mining social media to detect adverse drug reactions to newly-approved drugs, Ransohoff J et al. JAMA Oncology March 1, 2018. doi:10.1001/jamaoncol.2017.5688

Insurance type linked to cancer care delays, Wharam et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.2501.

Intervention boosted the rate of colorectal cancer screening, Source: Miller, D et al. Ann Inter Med 2018. DOI: 10.7326/M17-2315

Must Reads in FDA Actions

FDA Approves Lynparza for Certain Types of BC, FDA news release; 2018 Jan 12

Stereotactic Radiotherapy System Approved For BC, FDA news release; 2017 Dec 22

Perjeta Approved for Certain Type of Early BC, Genentech news release; 2017 Dec 20

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