AstraZeneca, Merck hit with 3-month delay for Lynparza's FDA filing in first-line prostate cancer

It’s been relatively smooth sailing for AstraZeneca and Merck’s Lynparza as it has gained indications in ovarian, breast, pancreatic and prostate cancer.

But on Thursday, the companies reported a snag as the FDA has delayed its target date for its decision on Lynparza in metastatic castration-resistant prostate cancer (mCRPC). The agency has pushed back the decision date to February to “provide further time for the full review of the submission,” Merck said.