A New Drug Application for a drug developed for the treatment of skin cancer has been withdrawn by one of the top biotech stocks, Array Biopharma Inc (NASDAQ:ARRY). It is understood that the withdrawal came after the results of the third phase trial proved disappointing and consequently raising concerns that the U.S. Food and Drug Administration would not approve it. This was done after thorough discussions had been held with the regulator and a review meeting held in the late cycle.
The drug, binimetinib, was being developed as a monotherapy for the treatment of NRAS-mutant melanoma. This is a kind of skin cancer where the tumor depends on mutation in order to grow and survive. In the 10,000 metastatic melanoma cases that are reported annually in the U.S., approximately a fifth of them are categorized as being NRAS-mutant melanoma.
Submission of the New Drug Application for binimetinib was done mid-last year. This was after a part of a Phase 3 trial which had compared dacarbazine with binimetinib in the treatment of metastatic or unresectable MRAS-mutant melanoma met the primary endpoint of the study. The primary endpoint was to improve progress free survival in comparison with treatment of MRAS-mutant melanoma using dacarbazine.
Other indications will not be discontinued
Despite the withdrawal of the application by one of the best biotech stocks, it is understood that other indications of the treatment will continue. As a combination therapy, binimetinib has showed positive results. This was evidenced last year when a combination of binimetinib and encorafenib in an early part of a phase 3 study that is ongoing brought out positive data. This was for the treatment of another kind of skin cancer – BRA-mutant melanoma.
In the study, the combination therapy performed better than Zelboraf, a mono therapy in the rate of progression-free survival. Consequently, the Boulder, Colorado-based pharmaceutical firm plans to submit a combination therapy application to the U.S. Food and Drug Administration. Additionally, Array BioPharma has also initiated a study to test the use of cetuximab and binimetinib for treatment of patients suffering from BRAFV600E-mutant colorectal cancer.
On Wednesday shares of Array Bipharma Inc rose by 2.74% to close the day at $9.38.