Bristol Myers' $10B Cancer Drug Opdivo Scores Expanded Use FDA Approval For Lung Cancer In Pre And Post-Surgery Setting

On Thursday, the FDA approved Bristol Myers Squibb & Co’s BMY Opdivo (nivolumab) for resectable non-small cell lung cancer (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.

The approval is based on results from the CheckMate-77T trial, the company’s second Phase 3 trial with an immunotherapy-based combination for resectable NSCLC.

Opdivo is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen.

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The risk of disease recurrence, progression, or death was reduced by 42% in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, with a median follow-up of 25.4 months.

In addition, 18-month event-free survival (EFS) was demonstrated in 70% of patients in the Opdivo arm, compared to 50% in the chemotherapy and placebo arm.

Furthermore, 25% of patients in the Opdivo arm achieved pathologic response (pCR) in the intent-to-treat population, while 4.7% of patients in the comparator arm achieved pCR.

As the U.S. pharma giant seeks to cover itself from the patent cliff related to top-selling drugs Eliquis (apixaban) and Opdivo (nivolumab), the company recently received FDA approval for Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for schizophrenia in adults.

As per its latest 10K filing, Eliquis’ U.S. patent is expected to expire in 2026.

Opdivo’s U.S. patent loss is expected in 2028, Europe in 2030, and Japan in 2031.

Another cancer drug, Yervoy (ipilimumab), is expected to lose market exclusivity in 2025 in the U.S. and Japan and 2026 in Europe.

Price Action: BMY stock is down 1.07% at $53.62 during the premarket session at last check Friday.

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