Friday September 21, 2018 0 comments
BOULDER -- Array BioPharma Inc. (NASDAQ: ARRY) today announced the European Commission (EC) has approved BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test.
The approval is applicable to all 28 European Union (EU) member states, as well as Liechtenstein, Iceland and Norway.
"With an even greater number of patients with advanced BRAF-mutant melanoma in Europe than in the U.S., we are delighted BRAFTOVI + MEKTOVI will be available to these patients who are in critical need of additional options that delay disease progression and improve overall survival," said Ron Squarer, Array CEO.
"Our European partner, Pierre Fabre, has a strong legacy in oncology, and with over a thousand employees dedicated to this therapeutic area, we are very pleased they have made BRAFTOVI + MEKTOVI a top priority for their team."
The EC approval is based on results from the Phase 3 COLUMBUS trial, of which the primary endpoint was median progression-free survival (mPFS). BRAFTOVI + MEKTOVI achieved an mPFS of nearly 15 months [14.9 months versus vemurafenib monotherapy at 7.3 months; hazard ratio (HR) 0.54 (95% CI, 0.41–0.71), p<0.0001].
BRAFTOVI + MEKTOVI is the first targeted treatment to achieve over 30 months median overall survival (OS). As published in The Lancet Oncology in September 2018, BRAFTOVI + MEKTOVI reduced the risk of death compared to vemurafenib [HR (0.61), (95% CI 0.47,0.79), p <0.0001].
Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib.
Detailed recommendations for the use of these products in the EU are described in the summary of product characteristics (SmPC), which are published in the European public assessment report (EPAR) and made available in all official EU languages at http://www.ema.europa.eu.
Array has exclusive rights to BRAFTOVI and MEKTOVI in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea, Medison exclusive rights to commercialize both products in Israel and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Latin America and Asia (excluding Japan and South Korea).
In June 2018, the U.S. Food and Drug Administration (FDA) approved BRAFTOVI + MEKTOVI for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.