Array wrestles FDA OK for its MEK/BRAF melanoma combo, to hit the pharmacy as Mektovi and Braftovi

Watch out Novartis.

Just a few weeks after turning up at ASCO with positive data to show off, Array BioPharma $ARRY has nailed an FDA approval for its MEK inhibitor binimetinib, which will be sold as Mektovi, as well as encorafenib — a BRAF inhibitor now dubbed Braftovi.

This is the first OK for its combo, which is slated to go up primarily against Novartis’ rival duo Tafinlar+Mekinist in the advanced BRAF mutant melanoma sector.

Ron Squarer, Array CEO

The news came out in bits and pieces. Array’s website had a promo up for the combo and the FDA posted the label and a note on the OK for Mektovi. But Array eventually posted its statement shortly before 2 pm ET.

The label shows the drug combo is to be used among patients with BRAF V600E or V600K mutations.

“Nearly half of patients diagnosed with metastatic melanoma test positive for the BRAFmutation,” said Valerie Guild, president of the AIM at Melanoma Foundation, adding the twin approval is “welcome news for the melanoma community.”

Jefferies has been weighing in on behalf of the biotech, giving them the edge in the head-to-head battle to come with the pharma giant. In a recent rundown on the combo for Array, analysts noted:

At ASCO 2018, ARRY presented additional data from COLUMBUS trial; mOS of 33.6mo for bini/enco combo vs. 23.5mo for enco alone vs. 16.9mo for vemurafenib, demonstrating higher potency of encorafenib vs. vemurafenib (mPFS of 14.9/9.6/7.3mo for combo/enco/vemurafenib). On OS/PFS data, ARRY notes that academic physicians/KOLs view bini/enco as the “best-in-class” although not a head-to-head study comparison on doublets. For safety/tolerability, ARRY notes physicians are comfortable with cross-study comparison; bini/enco’s lower rates of pyrexia (any grade, 18% on bini/enco vs. 50-60% for Tafinlar+Mekinist) & photosensitivity (vs. Zelboraf+Cotellic) will be well positioned with community-based physicians who are more concerned with safety issues.

Jefferies, for one, believes that Array can do better than what Novartis has done in this part of the melanoma market, where the pharma giant has been earning about $400 million for its combination.

That may be, but it was a sell-the-news kind of day on Wall Street. Array’s shares slid about 4% by the close.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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