BMY Gets FDA Nod for Label Expansion of Opdivo plus Yervoy Combo

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab).

The regulatory body approved Opdivo plus Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

Please note that Opdivo , as a single agent or in combination with Yervoy, was previously granted accelerated approval in MSI-H/dMMR CRC in adult and pediatric patients (12 years and older) who have progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.

The latest FDA approval converts this second-line indication to full approval for Opdivo monotherapy and expands the indication for Opdivo plus Yervoy into the first-line setting.

Shares of BMY have risen 7.9% in the past year against the industry’s decline of 20%.

More on FDA Approval of BMY’s Opdivo and Yervoy

The latest FDA approval was based on the results of the phase III CheckMate-8HW study.

This randomized, multicenter, open-label study is evaluating Opdivo plus Yervoy compared to Opdivo alone or chemotherapy in patients with unresectable MSI-H/dMMR mCRC.

Opdivo plus Yervoy met the dual primary endpoints of progression-free survival when compared to Opdivo monotherapy across all lines of therapy and chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review.

The combination demonstrated a reduction in the risk of disease progression or death by 79% as compared to chemotherapy in the first-line setting and by 38% versus Opdivo monotherapy across all lines of therapy.

The approval was granted more than two months ahead of the target action date of June 23, 2025.

The study is ongoing to assess various secondary endpoints, including overall survival.

CRC, a type of cancer that develops in the colon or rectum, is the third most diagnosed cancer in the United States and an aggressive one that is difficult to treat.

BMY Looks to Solidify Portfolio

Blockbuster immuno-oncology drug Opdivo continues to maintain momentum on consistent label expansions.

The FDA approval of Opdivo Qvantig injection for subcutaneous use is expected to help extend the impact of its immuno-oncology franchise to patients into the next decade.

The European Commission approved Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) also recently recommended approval of Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.

The CHMP also recommended approval of the subcutaneous formulation of Opdivo across multiple solid tumor indications.

BMY’s Growth Portfolio, comprising drugs like Reblozyl, Breyanzi, Camzyos and Opdualag, has stabilized its revenue base amid generic competition for its legacy drugs.

The company had earlier won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults, under the brand name Cobenfy. The approval of Cobenfy for schizophrenia broadens

BMY’s portfolio and validates the acquisition of Karuna Therapeutics.

BMY also recently agreed to acquire 2seventy bio, Inc. for $286 million. BMY and 2seventy bio have an agreement in place, whereby both companies equally share profits and losses related to the development, manufacturing and commercialization of Abecma in the United States.

BMY's Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Amicus Therapeutics, Inc. FOLD and ANI Pharmaceuticals, Inc. ANIP, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Amicus Therapeutics

In the past 60 days, estimates for Amicus’ earnings per share (EPS) have increased from 43 cents to 52 cents for 2025. During the same time frame, EPS estimates for 2026 have increased from 71 cents to 80 cents.

FOLD’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 45.42%.

ANI Pharmaceuticals

In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $5.54 to $6.35 for 2025. During the same period, EPS estimates for 2026 have increased from $6.75 to $7.21. Year to date, shares of ANIP have rallied 14%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%.

 

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