Array Biopharma Inc (NASDAQ:ARRY) has withdrawn the New Drug Application (NDA) it had filed for its skin cancer drug binimetinib. The company was developing the drug to be used as monotherapy treatment for NRAS-mutant melanoma. The decision to withdraw follows dismal results from a Phase 3 study which showed minimal chances of the drug being approved by FDA.
NRAS-Mutant melanoma is rare type of skin cancer where one develops tumor that is dependent on change for its survival as well as growth. Every year, the United States reports over 10,000 cases of metastatic melanoma. 20% of the reported cases are NRAS mutant melanoma
The withdrawal is as a result of intense communications and consultations with FDA including exploring several means to get the drug approved. Basing on feedback from FDA, Array decided to call off the study arguing that the clinical benefits discovered in Phase 3 clinical study could not offer sufficient ground to guarantee an FDA approval.
Array BioPharma in September 2016 experienced an 80% raise in its stock after announcing positive results from its first part of the Phase 3 trial. The Phase 3 trial examines the combination of binimetinib and encorafenib for treatment of BRAF-mutant melanoma.
The Boulder which is based in Colorado recently announced that other concurrent studies on binimetinib will go on as planned. The company further says it is committed to taking the study to the end and file for a combination therapy involving encorafenib and binimetinib used in the treatment of BRAF-mutated melanoma in 2017
Following the withdrawal of the new drug application (NDA), Array shares dropped by 2.3%.The shares have performed below the Zacks Medical-Biomed/Genetics. The company’s shares gained 3.9% at a time when the industry recorded an 8.2% increase.
The company is currently evaluating binimetinib in many other trials. The phase III study referred to as COLUMBUS evaluating encorafenib combined with binimetinib in BRAF-mutant melanoma patients. The company has also started the study of BEACON trial to examine encorafenib combined with cetuximab and binimetinib in BRAFV600E-mutant colorectal cancer patients.