More I-O early approvals bear scrutiny of FDA review

29 April 2021

There was more good news for Swiss company Roche (ROG: SIX) on Wednesday, as the US regulator’s scientific panel voted to maintain another Accelerated Approval for Tecentriq (atezolizumab).

The panel voted 10 to one in favor of keeping the approval, despite a lack of confirmatory data, for certain people with locally advanced or metastatic urothelial carcinoma, or bladder cancer.

On Tuesday the panel voted to keep another such early approval in place for the checkpoint blocker, in breast cancer. The Food and Drug Administration is expected to follow the recommendations.

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