Array BioPharma gets FDA Approval for Melanoma Combo

June 28, 2018  Source: FiercePharma 160

The U.S, Based Array BioPharma received FDA approval for its much-awaited BRAFTOVI capsules with the combination of MEKTOVI tablets for the treatment of patients with metastatic melanoma with a BRAFV600E or BRAFV600K mutation.

Array CEO Ron Squarer said the drugs will fill a "critical unmet need" and "represent a new standard of care" for the patients. But they'll face a couple of pharma giants in the field.

Phase 3 trial data showed Array's combo beat the Roche Zelboraf drug in patients with BRAF-mutant melanoma, supported the approval. Patients on the Array combo had a survival of 33.6 months, compared with 16.9 months for Zelboraf, Roche's drug

In the market, the Array Biopharma combo will challenge Zelboraf and Novartis' combo of Tafinlar and Mekinist. Both Pharma companies are practiced at oncology marketing and their drugs have the advantage of a head start.

CEO, Squarer said ‘Array's size gives it some advantages’. "As a smaller company, we are excited about working to make the patient experience as good as possible", adding that there's a "very concentrated group of prescribers," so the small biotech will be able to cover the ground with a small field force.

According to the company, the combo is now available through certain specialty pharmacies.

Array, which was founded 20 years ago, previously sought approval for Mektovi to treat NRAS-mutant melanoma, but the company pulled back the application last year after the FDA said efficacy data weren't strong. Now the company had its first two drug approvals on the same day.

By Ddu