Array BioPharma (NASDAQ:ARRY) slumps 13% premarket on robust volume in response to its announcement that it has withdrawn its New Drug Application (NDA) in the U.S. seeking approval of binimetinib for the treatment of NRAS mutation-positive melanoma, a rare subtype of skin cancer. The company's decision was based on feedback from the FDA that concluded that data from the Phase 3 NEMO study was not sufficient to demonstrate a clinical benefit.
The company says development will continue. The Phase 3 COLUMBUS trial, evaluating the combination of binimetinib and encorafenib for the treatment of BRAF-positive melanoma, remains on track for mid-year.
Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. Array licensed binimetinib to Novartis in 2010 but reacquired the rights after Novartis purchased GlaxoSmithKline's oncology business in early 2015.