Pfizer's Immunotherapy for Skin Cancer Gets FDA Approval
Pfizer, Inc. PFE and German partner Merck KGaA’s investigational cancer treatment, avelumab, was approved by the FDA for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive form of skin cancer.
Pfizer’s shares are up 5.5% so far this year, comparing unfavorably with the Zacks classified Large-Cap Pharma industry’s return of 6.6%.
Avelumab, a human anti-PD-L1 antibody, will be marketed by the trade name of Bavencio for intravenous use for the treatment of adults and pediatric patients 12 years and older with metastatic MCC.
However, Bavencio received accelerated approval. Continued approval in this indication will depend upon the verification and description of clinical benefit in confirmatory studies.
With the FDA approval, avelumab becomes the first immunotherapy option for the treatment of metastatic MCC, a rare form of skin cancer, which until now was being treated only with chemotherapy. Only less than 50% of the metastatic MCC patients survive more than one year and fewer than 20% survive beyond five years, thereby creating a vital need for treatment options. Avelumab is under review in EU for the indication.
The U.S. filing was based on positive data from the phase II study, JAVELIN Merkel 200. Avelumab was granted priority review for the treatment of metastatic MCC.
Pfizer collaborated with Merck KGaA in Nov 2014 to co-develop and co-commercialize avelumab. Currently, avelumab is being developed for many types of tumors including gastric/gastroesophageal junction, head and neck, Hodgkin's lymphoma, non-small cell lung, ovarian, renal cell carcinoma and urothelial (primarily bladder). Avelumab has also gained priority review in the U.S. for a second indication - for the treatment of metastatic urothelial carcinoma. A response from the FDA for the regulatory application should be out by Aug 27, 2017.
Interest in immunotherapy is building up fast. The basic concept of cancer immunotherapy or immuno-oncology is to utilize certain parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or by introducing immune system components into the body.
Merck & Co., Inc.’s MRK anti-PD-1 therapy, Keytruda, is being studied for more than 30 types of cancers. Amgen, Inc.’s AMGN Blincyto, a BiTE antibody, gained earlier-than-expected FDA approval in Dec 2014. Blincyto has the potential to be developed for other hematologic malignancies as well.
Smaller biotechs like Juno Therapeutics and Kite Pharma, Inc. KITE are also developing immuno-oncology treatments.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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