Bristol Myers lands first-line nod for dual immunotherapy
US pharma major Bristol Myers Squibb (NYSE: BMY) has received full approval from the US Food and Drug Administration for the use of Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with a specific form of colorectal cancer.
The decision clears the immunotherapy combination for use in adults and children aged 12 and older with unresectable or metastatic colorectal cancer that is microsatellite instability-high or mismatch repair deficient. It expands upon earlier indications and follows a priority review supported by Phase III data.
The approval is based on results from the CheckMate -8HW study, which compared the dual therapy to chemotherapy and monotherapy in patients with this aggressive cancer type. In newly diagnosed patients, the combination significantly delayed cancer progression compared to chemotherapy. It also outperformed Opdivo alone across treatment lines.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze