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Immunotherapy Drug Avelumab Granted Accelerated Approval by FDA

An immunotherapy drug called Avelumab, brand name Bavencio, has been granted accelerated approval by the FDA for metastatic Merkel cell carcinoma (mMCC). Avelumab is the first immunotherapy approved for mMCC and it is the only FDA-approved treatment for the disease.  mMCC is a rare and aggressive skin cancer.

Based on positive results in both tumor response and duration of response, the treatment is currently under clinical investigation in more than a dozen different types of cancers—including mesothelioma. In the largest study to date, Dr. Raffit Hassan of the National Cancer Institute (NCI) evaluated 53 patients with unresectable pleural or peritoneal mesothelioma. The median age was 66 and patients were assessed for 46 weeks. Dr. Raffit reported that in nearly 10 percent of patients, Avelumab reduced tumor size and 47.2 percent of patients showed stable disease. There were no treatment deaths.

The drug “is designed to potentially engage both the adaptive and innate immune systems” says pharmaceutical company Pfizer. By binding to PD-L1 (a protein on some normal cells and cancer cells), Avelumab is thought to “prevent tumor cells from using PD-L1 for protection against white blood cells, such as T-cells, exposing them to anti-tumor responses.”

The disease control rate in the study was 56.6 percent and all participants had experienced disease progression after undergoing standard chemotherapy treatments alone. Researchers concluded that Avelumab showed an acceptable safety profile and clinical activity in patients with unresectable mesothelioma.

About Immunotherapy

Immunotherapy is a type of treatment that promotes or supports the body’s immune system response to a disease such as cancer. Examples of some of the most promising immunotherapy treatments on the market today include Pembrolizumab (Keytruda), Nivolumab (Opdivo), and Ipilimumab (Yervoy). Immunotherapy is sometimes used alone, but is more commonly used after conventional treatment or combined with standard cancer treatments.

The research community is optimistic that more effective immunotherapies can be developed that will have a greater impact on the outlook for people with mesothelioma.



Gregoire, Marc. "What's the Place of Immunotherapy in Malignant Mesothelioma Treatments?" Cell Adhesion & Migration 4.1 (2010): 153-61. U.S. National Library of Medicine, National Institutes of Health (NIH). Web. 02 May 2017.

Hassan, Raffit, Anish Thomas, Manish R. Patel, John J. Nemunaitis, and Jaafar Bennouna. "Avelumab (MSB0010718C; Anti-PD-L1) in Patients with Advanced Unresectable Mesothelioma from the JAVELIN Solid Tumor Phase Ib Trial: Safety, Clinical Activity, and PD-L1 Expression." ASCO University. American Society of Clinical Oncology, 2016. Web. 02 May 2017.

"Immune Checkpoint Inhibitors to Treat Cancer." American Cancer Society. American Cancer Society, Inc., 2017. Web. 02 May 2017.

Lauer, Melissa. "FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma." Pfizer. Pfizer, Inc., 23 Mar. 2017. Web. 02 May 2017.

"Understanding Immunotherapy." Cancer.Net. American Society of Clinical Oncology (ASCO), 16 May 2016. Web. 02 May 2017.