Array BioPharma submits melanoma drug for FDA approval

BOULDER — Array BioPharma (Nasdaq: ARRY) this week submitted a New Drug Application with the U.S. Food and Drug Administration for the use of drug candidate binimetinib in the treatment of NRAS-mutant melanoma.

The submission is the first for Boulder-based Array, which has several drugs in the development stage. It comes on the heels of positive Phase 3 trial results for binimetinib that were released earlier this month.

Array shares spiked as high as $3.82 Friday morning from Thursday’s close of $3.56 before gradually settling back to $3.62 by mid-afternoon trading.

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If granted, FDA approval of the first NDA could mark just the beginning for binimetinib. The drug is being examined in a pair of other Phase 3 trials. One is looking at the use of binimetinib in combination with Array drug encorafenib in the treatment of BRAF-mutant melanoma. Another is looking at the combination of both of those drugs, along with Merck drug Erbitux, in the treatment of colorectal cancer.

Another Array drug, selumetinib, is licensed by AstraZeneca, which is conducting Phase 3 trials looking at the drug in the treatment of lung cancer and thyroid cancer.