Merck-Pfizer Avelumab on FDA Fast Track

08.10.2015 -

After previously receiving Orphan Drug status for avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody to treat the rare and aggressive skin cancer Merkel cell carcinoma (MCC), Merck KGaA and Pfizer have now been awarded Fast Track status from the US Food and Drug Administration (FDA).

Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. Such products are eligible for accelerated approval and priority review, if the relevant criteria are met, and rolling FDA review of marketing applications.

The clinical development program for avelumab launched by the global strategic immuno-oncology alliance between the German and US drugmakers now includes more than 1,000 patients who have been treated across more than 15 tumor types. These include breast cancer, gastric/gastroesophageal cancer, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial cancer.

Avelumab was initially discovered and developed by Merck. Along with jointly developing and commercializing the cancer treatment, the two companies’ alliance will also advance Pfizer’s PD-1 antibody.

Altogether, Merck and Pfizer plan to collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials. Many of these are expected to commence before the end of this year.