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January 25, 2019updated 28 Jan 2019 6:19am

BMS withdraws US sBLA for Opdivo-Yervoy combination for NSCLC

Bristol-Myers Squibb (BMS) has announced it has voluntarily withdrawn its supplemental biologics license application (sBLA) for its Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy for non-small cell lung cancer (NSCLC).

By Allie Nawrat

Bristol-Myers Squibb (BMS) has announced it has voluntarily withdrawn its supplemental biologics license application (sBLA) for its Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy for non-small cell lung cancer (NSCLC).

The US pharma company submitted overall survival (OS) analysis for NSCLC patients with tumour mutational burden (TMB) to add to its sBLA in October 2018.

The US Food and Drugs Administration (FDA) deemed this to be a significant amendment, so extended the review period for the therapy to May 2019.

However, following discussions with the FDA, BMS concluded that further evidence beyond its OS analysis was necessary to prove the relationship between TMB and programmed death-ligand 1, and establish the impact of the combination on NSCLC patients.

BMS has therefore decided to wait until it has the final first part data from its ongoing Phase III Checkmate-227 trial, which is expected in the first half of 2019.

This announcement was made in the company’s fourth quarter (Q4) earnings report. Opdivo and Yervoy are both prioritised drugs for BMS. Opdivo’s global revenue for Q4 2018 was $1.8bn, an increase of 33% on Q4 2017. Total global revenue for Yervoy in Q4 2018 was $384m, 43% higher than Q4 2017.

In the 12 months to December 2018, globally Opdivo earnt BMS $6.7bn and Yervoy revenues were $1.3bn, representing a 32% and a 7% increase respectively on the previous year.

US revenues for Opdivo were $1.1bn in Q4 and totalled $4.2bn in 2018. Yervoy’s revenue in the US was $273m in Q4 and $908m in the full year.

BMS’s total revenue for Q4 was $6bn, a 10% increase from Q4 2017. Full-year revenues reached $22.6bn, compared to $20.8bn in 2017.

The Opdivo-Yervoy combination therapy has been approved by the FDA for renal cell carcinoma, metastatic melanoma and colorectal cancer.

The combination treatment has also recently been approved by the European Commission for first line treatment for renal cell carcinoma.

Opdivo alone has been approved for patients with advanced NSCLC since 2015.

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