Pfizer, Inc. (PFE - Free Report) and German partner Merck KGaA announced that the Biologics License Application (sBLA) for their experimental anti-PD-L1 monoclonal antibody, avelumab, has been accepted for priority review by the FDA.
Pfizer shares rose 0.7% in the past one month comparing favorably with a decline of the same magnitude for the Zacks classified Large-Cap Pharma industry.
Coming back to the latest press release, the companies are looking to get avelumab approved for the treatment of metastatic Merkel cell carcinoma, a rare type of skin cancer. With the FDA granting priority review, a response should be out within six months from the day of filing.
The U.S. filing was based on positive data from the phase II study, JAVELIN Merkel 200. If approved by the FDA, avelumab could be the first immunotherapy option for the treatment of metastatic MCC. Avelumab enjoys Breakthrough Therapy, Fast Track and Orphan Drug status in the U.S. for the MCC indication. This is an aggressive disease with less than 20% of patients surviving beyond five years, thereby creating a vital need for treatment options.
Avelumab is under review in EU for the indication.
We note that in Nov 2014, Merck KGaA entered into a strategic collaboration with Pfizer to co-develop and co-commercialize avelumab. Currently, avelumab is being developed for more than 15 types of tumors including breast, gastric/gastroesophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial (primarily bladder). Previously, the companies had said they intend to commercially launch avelumab in 2017, assuming successful development and a subsequent approval of the candidate. Thereafter, they aim to make at least one additional launch every year through 2022.
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 - Free Report) anti-PD-1 therapy, Keytruda, is being studied for more than 30 types of cancers. Amgen, Inc.’s (AMGN - Free Report) 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 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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