Bristol-Myers Squibb Company BMY announced that the European Medicines Agency or EMA's Committee for Medicinal Products for Human Use (“CHMP”) has recommended approval of its blockbuster immuno-oncology drug, Opdivo (nivolumab), in combination with chemotherapy for yet another indication.Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, has been recommended for approval for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (“GEJ”), or esophageal adenocarcinoma (“EAC”) whose tumors express PD-L1 with a combined positive score ("CPS") of ≥ 5. The opinion will now be reviewed by the European Commission.The positive CHMP opinion was based on data from the phase III CheckMate -649 study that compared first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) versus treatment with chemotherapy alone.Data from the same showed that treatment with Opdivo plus chemotherapy led to a statistically significant and clinically meaningful improvement in overall survival and progression-free survival in patients with unresectable advanced/metastatic gastric cancer, GEJ cancer or EAC whose tumors express PD-L1 with a CPS ≥ 5 – the primary endpoint.Shares of Bristol Myers have lost 1.1% so far this year against the industry’s growth of 0.9%.Image Source: Zacks Investment ResearchIn April 2021, the FDA approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression status.Opdivo is already approved in several countries for multiple indications including melanoma, renal cell carcinoma, second-line non-small-cell lung cancer, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck.Bristol Myers continues to evaluate Opdivo alone or in combination therapies with other anti-cancer agents. In the first six months of 2021, Opdivo generated sales worth $3.6 billion, reflecting an increase of 6% year over year. Label expansion of the drug should boost sales further in the days ahead.However, competition remains stiff in the immune-oncology space from the likes of Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq in key indications.Zacks Rank & Key PickBristol Myers currently carries a Zacks Rank #3 (Hold). A top-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. REGN, which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Regeneron’s earnings estimates have been revised 17.8% upward for 2021 and 13.8% upward for 2022 over the past 60 days. The stock has surged 35% year to date. Breakout Biotech Stocks with Triple-Digit Profit Potential The biotech sector is projected to surge beyond $2.4 trillion by 2028 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Recommendations from previous editions of this report have produced gains of +205%, +258% and +477%. The stocks in this report could perform even better.See these 7 breakthrough stocks now>>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research