CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo

Bristol Myers BMY announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of Opdivo (nivolumab) for another indication.

The CHMP 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 (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.

The positive CHMP opinion was based on results from the CheckMate -77T trial. Results from this study showed a significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo, followed by surgery and adjuvant placebo.

The CheckMate-77T study also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response and major pathologic response (MPR). CheckMate-77T is ongoing to assess another key secondary endpoint of overall survival.

We remind investors that in October 2024, the FDA approved Opdivo for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.

This approval was also based on results from the CheckMate-77T study, which is the second positive phase III study trial with an immunotherapy-based combination for the treatment of resectable non-metastatic NSCLC.

Per BMY, Opdivo is the only immunotherapy treatment with phase III data in both the neoadjuvant-only and perioperative NSCLC treatment settings. Opdivo and Opdivo-based combinations have also shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types — lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

Shares of BMY have risen 21.4% in the past year against the industry’s decline of 7.1%.

Another Positive CHMP Opinion for Opdivo

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

Nivolumab for subcutaneous use, co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

The positive CHMP opinion is based on results from the CheckMate-67T trial, as well as additional data demonstrating comparable pharmacokinetics and safety profiles between subcutaneous use of Opdivo and the intravenous formulation.

In December 2024, the FDA approved nivolumab and hyaluronidase-nvhy, under the brand name Opdivo Qvantig.

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

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

BMY had earlier won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults. The drug was approved under the brand name Cobenfy. The approval of Cobenfy for schizophrenia broadens BMY’s portfolio and validates the acquisition of Karuna Therapeutics.

Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades. The initial uptake is encouraging, with sales of $10 million in 2024. This drug is expected to contribute meaningfully to BMY’s top line in the coming years as the company looks to expand the drug’s label into other indications (Alzheimer's disease and bipolar 1 disorder).

Last month, BMY agreed to acquire 2seventy bio, Inc. TSVT 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.

The acquisition is expected to be closed in the second quarter of 2025. TSVT has been facing challenges for quite some time now and is looking to maximize shareholder value.

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 42 cents to 52 cents for 2025. During the same time frame, EPS estimates for 2026 have increased from 70 cents to 78 cents.

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 21.2%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%.

 

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

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research