Bristol Myers' $10 billion cancer drug Opdivo receives expanded FDA approval to treat lung cancer before and after surgery

The FDA granted approval on Thursday Bristol Myers Squibb & Co (NYSE:BMY) Opdivo (nivolumab) for resectable non-small cell lung cancer (NSCLC) and without 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 study of an immunotherapy-based combination for resectable NSCLC.

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

Also Read: Bristol Myers-2seventy Bio Halt Phase 3 Trial for Abecma in Newly Diagnosed Myeloma Patients Accelerates Path to Profitability.

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 arms, with a median follow-up of 25.4 months.

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

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

As the US pharmaceutical giant tries to protect itself from the patent cliff associated with its best-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.

According to its latest 10K filing, Eliquis' US patent is expected to expire in 2026.

Opdivo's patent loss is expected in the US in 2028, in Europe in 2030 and in Japan in 2031.

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

Price promotion: BMY shares were down 1.07% at $53.62 during the pre-market session at last check on Friday.

Read more:

Photo via Shutterstock

Next up: Transform your trading with Benzinga Edge's unique market trading ideas and tools. Click now to get unique insights This can give you an edge in today's competitive market.

Get the latest stock analysis from Benzinga?

The story continues

This article: Bristol Myers' $10 billion cancer drug Opdivo gets expanded FDA approval for lung cancer in pre- and post-surgical treatment originally appeared on Benzinga.com

© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.