This article is more than 5 years old. Information may no longer be current.

Genentech seeks approval for skin cancer drug in US, Europe

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Genentech, a member of the Roche Group, has submitted a new drug application to the FDA for vemurafenib to treat patients with BRAF V600 mutation-positive metastatic melanoma, according to a company press release. In addition, Roche has submitted a marketing authorization application to the European Medicines Agency for vemurafenib in the same indication, as well as an application for a companion diagnostic.

Vemurafenib is a BRAF inhibitor designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma, according to the release.

The submissions are based on results from two clinical trials (BRIM2 and BRIM3) that evaluated vemurafenib in BRAF V600 mutation-positive metastatic melanoma, as determined by the investigational companion diagnostic test also being developed by Roche. A premarket approval application for the Cobas 4800 BRAF V600 Mutation Test has been submitted in the US. The test will also be registered in Europe.

BRIM3 — a global, randomized, open-label, controlled, multicenter, phase 3 study — compared vemurafenib with dacarbazine in 675 patients with previously untreated BRAF V600 mutation-positive, unresected or locally advanced metastatic melanoma. The co-primary endpoints were met, and data showed that OS and PFS were superior in the vemurafenib arm compared with the dacarbazine arm. The safety profile was consistent with previous vemurafenib studies, according to the release.

Full data from BRIM3 will be presented at the 2011 ASCO Annual Meeting on June 5 in Chicago.

BRIM2 is a global, single-arm, multicenter, open-label, phase 2 study of 132 patients with previously treated BRAF V600 mutation-positive metastatic melanoma. The primary endpoint was overall response rate. Vemurafenib was associated with a reduction in tumor size in 52% of trial participants. Median PFS among these patients was 6.2 months, according to the release. Updated data from BRIM2 will also be presented at the ASCO Annual Meeting.

The most frequent grade 3 adverse event observed in clinical trials of vemurafenib was cutaneous squamous cell carcinoma. The most common adverse events were rash, increased sun sensitivity, joint pain, hair loss and fatigue. Possible serious adverse effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats and allergic reactions.

Follow HemOncToday.com on Twitter.