AstraZeneca and Merck said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza tablets, as monotherapy for adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
