Skip to main content
Premium Trial:

Request an Annual Quote

FDA Approves Roche's Companion Dx and Drug for Melanoma

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's drug and companion diagnostic test for late-stage unresectable melanoma.

The agency today approved Zelboraf (vemurafenib), co-developed with Daiichi Sankyo, for the treatment of patients with melanoma whose tumors express a gene mutation known as BRAF V600E. At the same time it approved the cobas 4800 BRAF V600 Mutation Test for determining whether a patient's melanoma cells have the mutation.

FDA reviewed Zelboraf under its priority review program that provides for an expedited six-month review of drugs "that may offer major advances in treatment or that provide a treatment when no adequate therapy exists," it said in a statement. Zelboraf was approved ahead of its Oct. 28 goal date, while the cobas 4800 BRAF V600 test was approved ahead of its Nov.12 goal date.

"Today's approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner," said Alberto Gutierrez, director the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health.

In a statement, Roche said that the cobas test, which is PCR-based, was clinically validated in two studies to identify tumors carrying the BRAF V600E mutation.

"The test has several advantages compared to Sanger sequencing, a commonly used method, including greater sensitivity and reliability for detecting mutations and quicker results, allowing doctors to know whether a person with inoperable or metastatic melanoma is eligible for treatment with Zelboraf," Roche said.

The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.