Monday July 30, 2018 0 comments
BOULDER -- Array BioPharma Inc. (NASDAQ: ARRY) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation.
The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The final EC decision, expected by the end of September, will be applicable to all 28 EU member states, as well as Liechtenstein, Iceland and Norway, the company said.
"Following the recent U.S. FDA approval of BRAFTOVI + MEKTOVI for advanced BRAF-mutant melanoma, we are pleased to move one step closer to European approval," said Ron Squarer, Array’s CEO.
"We are proud that the combination of BRAFTOVI + MEKTOVI represents a new standard of care for BRAF-mutant melanoma patients in critical need of additional treatment options."
Array said the positive CHMP opinion is based on results from the Phase 3 COLUMBUS trial, which demonstrated that the combination BRAFTOVI + MEKTOVI achieved a median progression-free survival (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].
In June 2018, Array also announced updated results from the COLUMBUS trial, which demonstrated that BRAFTOVI + MEKTOVI was the first targeted therapy to achieve over 30 months overall survival (OS) in a Phase 3 trial and reduced the risk of death compared to treatment with 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 as a monotherapy.
In the U.S., BRAFTOVI + MEKTOVI are approved for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.
Only 5% of patients who received BRAFTOVI + MEKTOVI discontinued treatment due to adverse reactions. The most common adverse reactions (≥25%) in patients receiving BRAFTOVI + MEKTOVI were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.
Detailed recommendations for the use of these products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official EU languages after the marketing authorization has been granted by the EC.
Pierre Fabre has exclusive rights to commercialize both products in Europe, Asia and Latin America.