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FDA Grants Accelerated Approval for Immunotherapy Drug Bavencio (Avelumab)

The FDA has granted accelerated approval for Bavencio (Avelumab)—the first immunotherapy approved for metastatic Merkel cell carcinoma (mMCC). Avelumab is also the only FDA-approved treatment for mMCC—a rare and aggressive skin cancer. Because the drug showed positive results in both tumor response and duration of response, the treatment is currently under clinical investigation in at least 15 difficult-to-treat cancers—including mesothelioma.

In the largest study to date, for 46 weeks, Dr. Raffit Hassan of the National Cancer Institute (NCI) and his team evaluated 53 patients with unresectable pleural or peritoneal mesothelioma. The median age was 66. Dr. Raffit reported that there were no treatment deaths and 47.2 percent of patients showed stable disease. Further, in nearly 10 percent of patients, Avelumab reduced tumor size.

According to pharmaceutical company Pfizer, the drug “is designed to potentially engage both the adaptive and innate immune systems.” 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. It is sometimes used alone, but is more commonly combined with standard cancer treatments or used after conventional treatment. Examples of some of the most promising immunotherapy treatments on the market today include Pembrolizumab (Keytruda), Nivolumab (Opdivo), and Ipilimumab (Yervoy).

Researchers are optimistic that more effective immunotherapies can be developed that will have a greater impact on the outlook for people with mesothelioma.

Studies that are actively recruiting for therapies such as Avelumab. These groundbreaking therapies could be effective in helping treat your specific type of 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.