FDA grants Merck and Pfizer priority review for PD-L1 cell treatment
pharmafile | November 19, 2015 | News story | |
The FDA has granted Merck and Pfizer’s avelumab Breakthrough Therapy Designation for the treatment of patients with metastatic merkel cell carcinoma (MCC).
The drug, which the two companies have collaborated on since November2014, is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, which will be given to patients who have progressed MCC after at least one previous chemotherapy regimen.
The Breakthrough Therapy designation is based on the preliminary evaluation of clinical data from the global Phase II study, JAVELIN Merkel 200 which is a multicenter, single-arm, open-label Phase II study with a primary objective of overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study, which enrolled 88 patients, is being conducted in sites across Asia Pacific, Australia, Europe and North America.
The clinical development program for avelumab now includes more than 1,400 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial cancer.
Dr Luciano Rossetti, head of global research & development at Merck’s biopharma business says: “Metastatic merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients.” He went on to say: “With this Breakthrough Therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options.”
Dr Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology says: “In less than two months, the alliance between Merck and Pfizer has achieved its third regulatory milestone for avelumab, including Orphan Drug designation and Fast Track designation granted in September and October.” He went on to say: “We are very pleased with the progress of the JAVELIN clinical development program and we are looking forward to presenting additional data on the potential of this investigational compound in Merkel cell carcinoma and other tumour types in 2016.”
Yasmita Kumar
