BOULDER — Array BioPharma Inc. (Nasdaq: ARRY) announced on Sunday that it withdrew its new drug application from the U.S. Food and Drug Administration.
Array had filed an application for binimetinib monotherapy, which treats a rare subset of skin cancer called NRAS-mutant melanoma. The application had been filed with the FDA’s Division of Oncology Products.
The decision to withdraw was based on the fact that Array concluded the benefit demonstrated in clinical trials would not be sufficient to support the approval of the new drug application.
Ongoing clinical trials for binimetinib will continue, according to a news release from the company. The decision to withdraw will not impact planned upcoming phases of trials for the drug, which will start later this year.
That trial, the Columbus trial, had results published in November, said Tricia Haugeto, a spokesperson for Array. She said Array plans to file a new drug application in relation to that study over the summer.