An advisory committee of the US Food and Drug Administration will question on Tuesday whether rociletinib, the lung cancer drug of USA-based Clovis Oncology (Nasdaq: CLVS), is any more effective than drugs which are already available.
However, ahead of the meeting, negative briefing papers from FDA staffers saw Clovis shares plunge as much as19% on Monday.
Rociletinib is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) mutation positive metastatic non-small cell lung cancer, who have been previously treated with EGFR-targeted therapy and who have the EGFR T790M mutation, as detected by an FDA-approved test.
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
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze