The Zacks Analyst Blog Highlights: Pfizer, Roche, Merck, Allergan and J&J
Pfizer’s biosimilar versions of Roche’s other cancer drugs Rituxan and Avastin (Zirabev) are also under review in the United States with FDA decisions on all expected in 2019. Pfizer and partner Merck KGaA announced that its regulatory filing in the EU looking for approval of Bavencio (avelumab), in combination with Inlyta (axitinib) for advanced renal cell carcinoma (“RCC”), was validated for review by the European Medicines Agency. EU Nod to Merck’s Keytruda Combo in Difficult Lung Cancer: Merck announced that the European Commission granted marketing approval to Keytruda, in combination with chemotherapy, as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC – a difficult-to-treat lung cancer patient population. The FDA granted the application a normal review period of 10 months and will give its decision in the fourth quarter of 2019. If approved, ubrogepant would be the first oral CGRP antibody to get approval for migraine and may be used in conjunction with other available migraine treatment.