Merck KGaA And Pfizer Get FDA Approval Of Checkpoint Inhibitor "Avelumab" For Rare Merkel Cell Skin Cancer Therapy
Merck KGaA and Pfizer, Inc. (NYSE:PFE) have done it. The biopharma partners came away with their first FDA approval of the checkpoint inhibitor avelumab, making it the fourth drug in this category to make it to the market. They beat AstraZeneca, which will now angle for its first approval of durvalumab as the 5th checkpoint.
Written by John Carroll
The FDA gave out its approval for Merkel cell carcinoma under an accelerated approval process. The therapy, the first for a rare form of skin cancer, has also been given breakthrough drug status. The drug is currently in 30 clinical programs as the two players look to wedge their way into a multibillion-dollar market for drugs that are gaining wide use in treating cancer.
The approval marks another big advance for Pfizer, which paid $850 million upfront to partner with Germany’s Merck — a record sum. The approval of this anti-PD-L1 IgG1 monoclonal antibody also marks a major win for Merck KGaA, which has suffered through more than a decade without a blockbuster OK. Merck KGaA also came away with a package of regulatory and commercial milestones on avelumab worth up to $2 billion when it tied up with Pfizer in 2014.
The therapy will be sold as Bavencio. A spokesperson for Pfizer said the drug will cost $13,000 a month wholesale — ahead of payer discounts.
The new approval also marks just how quickly the FDA can move when it wants to. The OK is based on a single arm study including 88 patients. Of the 88 patients who received Bavencio in the trial, says the FDA, 33% experienced complete or partial shrinkage of their tumors. The response lasted for more than six months in 86% of responding patients and more than 12 months in 45% of responding patients.
AstraZeneca PLC (NYSE:AZN) rejigged its development campaign for the next checkpoint in the pipeline, relying heavily on its work in combining it with the CTLA-4 checkpoint tremelimumab to try and leapfrog the fast moving trio in the lead: Merck, Bristol-Myers Squibb Co. (NYSE:BMY) and Roche/Genentech. They’ll be staring down some of the biggest rivals in the industry in a make-or-beak effort to distinguish its R&D operations, which has had several successes in cancer but continues to be plagued by setbacks in the clinic and at the FDA.
Said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence:
“While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now. The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.”
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