French diagnostics developer bioMérieux hitched up with GlaxoSmithKline ($GSK) to develop companion diagnostics for a pair of the drugmaker's melanoma treatments, and now the duo has something to celebrate as the FDA approved all three.
GSK's dabrafenib and trametinib--branded as Tafinlar and Mekinist--are designed to treat skin cancers that express the BRAF V600E or V600K gene mutations, and bioMérieux's THxID BRAF test is a molecular diagnostic that can find the drugs' ideal patients.
The two companies united in 2010 and submitted combined clinical data to the agency last year, finding that Tafinlar delayed tumor growth by an average of 2.4 months compared to standard chemotherapy and Mekinist delayed it by 3.3 months, all while identifying study participants with bioMérieux's BRAF-mutation test.
The agency's blessing is something of an affirmation for companion diagnostics, CDRH's Alberto Gutierrez said, as the FDA has now approved four gene-expression-targeted melanoma therapies in the past two years.
"The co-approval of Tafinlar and Mekinist and the second companion diagnostic for BRAF mutation detection demonstrates the commitment of pharmaceutical and diagnostic partners to develop products that detect and target the molecular drivers of cancer," Gutierrez said in a statement.
THxID BRAF follows Roche's ($RHHBY) Cobas V600, a BRAF-charting assay paired with Genentech's melanoma-fighting Zelboraf.
The approval falls in line with bioMérieux's plans for a big 2013, as the company is eyeing launches of a sample incubator with imaging capabilities, a new automated blood culture system and the Vidas 3, the next generation of the company's immunoassay platform. Companion diagnostics--or "theranostics," as bioMérieux's internal portmanteau reads--are of increasing importance as the company looks to capitalize on personalized medicine through 2015.
In 2013, bioMérieux is expecting growth between 3% and 5%, good for up to $2.1 billion in annual revenue. THxID BRAF, on the market in Europe since April, is unlikely to have an immediate impact on revenue, a spokesman said, but the company expects to test about 150,000 patients a year once the drugs catch on. And bioMérieux is aiming for expanded indications, eventually clearing the test for colorectal and non-small cell lung cancers, which could add about 450,000 patients per year, the company said.
The two drugs are approved as individual therapies, not as the combo attack GSK believes could prevent melanoma from returning after surgery. The London-based company is in the midst of a late-stage study on a Tafinlar-Mekinist combination.
- read the release
- check out FierceBiotech's take on GSK
Editor's note: This story has been updated to include comments from bioMérieux.