All Oncology News

The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab (Keytruda) alone or in combination with platinum and 5-fluorouracil chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

The FDA has added 3 months to the review period for a supplemental new drug application for ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, making the new action date May 24, 2019.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for first-line treatment with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in patients with metastatic squamous non–small cell lung cancer.