FDA issued a revised draft guidance, “Use of Investigational Tobacco Products,” intended to assist tobacco product manufacturers, academic institutions and institutional review boards studying tobacco products.
The European Commission has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
FDA has accepted a new supplemental Biologics License Application for Keytruda as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.
EMD Serono and Pfizer Inc. announced the FDA has accepted for Priority Review the supplemental Biologics License Application for Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma. The application has been given a target action date in June 2019.
FDA has approved Cablivi (caplacizumab-yhdp) injection in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vizimpro (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations. The CHMP's opinion will now be reviewed by the European Commission
Genentech has submitted a supplemental Biologics License Application to the FDA for Kadcyla (ado-trastuzumab emtansine) for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.
Merck KGaA and GSK have agreed to jointly develop and commercialize M7824 (bintrafusp alfa). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers.
FDA has initiated enforcement action against several retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.
The Lung Cancer Master Protocol is undergoing a major expansion to include patients with all non-small cell lung cancers.
