The approval late last month of Bavencio, a treatment for an unusual and aggressive form of skin cancer, relied on two Food and Drug Administration programs designed to expedite drug review and usher them to the market faster.
A joint product of Pfizer Inc. in the United States and Merck KGaA in Germany,
combats Merkel cell carcinoma by boosting a patient’s immune response to battle the tumors, according to a joint press release issued March 23.
Although the intravenous medication was cleared through the Breakthrough Therapy Designation and Priority Review processes, ongoing tests will ultimately confirm its efficacy, the release said.
So far, 33 percent of patients receiving
responded well to the medication, with 86 percent reporting positive results six months after treatment, the announcement said.
contains avelumab, an immune-boosting ingredient developed through a collaboration between Merck and Pfizer
Bavencio's journey has included years of hard work – from the scientists who discovered this molecule in our labs, to our alliance with Pfizer and to the study participants and investigators worldwide,” said Merck CEO and board member Belen Garijo. “We are grateful to all who have made it possible for us to bring this important new treatment option to patients."
Massachusetts-based EMD Serono, Merck’s U.S. and Canadian biopharmaceutical subsidiary, will market the drug, the release said.
FDA’s accelerated review speeds skin cancer treatment to market