XTANDI (enzalutamide) capsules received FDA approval for Supplemental New Drug Application to update the U.S product labeling. The drug is sponsored by Astellas Pharma Inc. and Pfizer Inc. The SNDA is based on new data from the TERRAIN study which indicated improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were...
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.
