September 24, 2018

Array gets European approval for drug combination

BOULDER — Array BioPharma Inc. (Nasdaq: ARRY) received European Commission approval for the use of Braftovi in combination with Mektovi in the treatment of adult patients with a certain cancer.

The drugs are approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF mutation. The approval is applicable to all 28 European Union 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, chief executive officer, in a prepared statement. “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.”

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The EC approval was based on the results of the third phase of the clinical Columbus trial. The combination was approved in June by the U.S. Food and Drug Administration.

Only 5 percent of patients stopped the treatment due to adverse side effects, which can include fatigue, nausea, vomiting and abdominal pain, among other symptoms.

Array has exclusive rights to Braftovi + Mektovi in the U.S. and Canada. Ono Pharmaceutical has rights to commercialize in Japan and South Korea, Medison has rights to commercialize in Israel and Pierre Fabre has rights in Europe, Latin America and parts of Asia.

 

BOULDER — Array BioPharma Inc. (Nasdaq: ARRY) received European Commission approval for the use of Braftovi in combination with Mektovi in the treatment of adult patients with a certain cancer.

The drugs are approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF mutation. The approval is applicable to all 28 European Union 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…

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