FDA nod for Tecentriq triple-combo for advanced melanoma

31 July 2020

The US Food and Drug Administration has granted accelerated approval for the combination of Tecentriq (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients, Swiss pharma giant Roche (ROG: SIX) and subsidiary Genentech announced this morning.

The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines, the companies said.

As well as priority review, the supplemental Biologics License Application (sBLA) review was also conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

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

Subscribe Now

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