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BMS aims for US approval of Opdivo combo in stomach cancer
US regulator has set a goal date for a decision on 25 May
The US Food and Drug Administration (FDA) has accepted a priority review for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) plus chemotherapy combination in stomach cancer.
The US regulator will review the combo treatment for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or oesophageal adenocarcinoma (EAC).
The FDA has set a prescription drug user fee act (PDUFA) goal date for a decision on BMS’ immunotherapy regimen of 25 May.
In the phase 3 CheckMate-649 trial, first-line treatment with Opdivo plus either FOLFOX or CapeOX chemotherapy regimens led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with advanced gastric cancer, GEJC or EAC with PD-L1-positive tumours. ....

Ian Waxman , Yervoy Ipilimumab , Bristol Myers Squibb , European Commission , Drug Administration , Merck Co , ஈயந் மெழுகு , பிரிஸ்டல் மைஸ் ஸ்க்விப்ப் , ஐரோப்பிய தரகு , மெர்க் இணை ,