Bavencio treatment for Merkel cell carcinoma patients gains FDA approval

EMD Serano, the biopharmaceutical business of Merck KGaA, and Pfizer Inc. recently received approval from the U.S. Food and Drug Administration to market Bavencio Injection 20 mg/mL for intravenous use.
Bavencio helps treat adults and pediatrics patients 12 years and older with Merkel cell carcinoma (mMCC).
“At the heart of this FDA approval is our drive to make a meaningful difference for patients with hard-to-treat cancers like metastatic Merkel cell carcinoma,” Belén Garijo, CEO of Healthcare of Merck KGaA, said. “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. We are grateful to all who have made it possible for us to bring this important new treatment option to patients.”
The FDA’s approval comes after the conclusion of the Javelin Markel 200 trial, which proved the efficacy and safety of Bavencio. The drug is now the first FDA-approved therapy for patients with mMCC.
“Today is a significant milestone for people fighting metastatic Merkel cell carcinoma, who until now have not had any options beyond chemotherapy,” Albert Bourla, group president of Pfizer Innovative Health, said. “This approval demonstrates the power of collaboration to accelerate meaningful new choices for cancer patients.”