March 23, 2017
The biopharma partners Merck KGaA and Pfizer came away with their first FDA approval of the checkpoint inhibitor avelumab. This made it the fourth drug in this category to make it to the market. The FDA approves this for Merkel cell carcinoma under an accelerated approval process. The drug is currently in 30 clinical programs. The two pharma giants look to wedge their way into a multibillion-dollar market for drugs that are gaining wide use in treating cancer.
Pfizer 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 FDA OK. The company came away with a package of commercial and regulatory milestones on avelumab worth up to $2 billion when it tied up with Pfizer in 2014.
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, said: “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.”