During the morning session, the committee will discuss supplemental new drug application (sNDA) 208558/010 for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy.

During the afternoon session, the committee will discuss supplemental biologics license application (sBLA) 125514/066 for KEYTRUDA (pembrolizumab) for injection, submitted by Merck Sharpe & Dohme Corp. The proposed indication (use) for this product is for the treatment of patients with bacillus Calmette-Guérin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.