The UK National Institute for Health and Care Excellence (NICE) has recommended pembrolizumab (Keytruda) manufactured by MSD to treat melanoma, the most common form of skin cancer.
Regulatory
FDA Fast Tracks Treatment for Select Stage IIB to IV Malignant Melanoma
KIN-2787 is a potential treatment for BRAF class II or III alteration-positive and/or NRAS mutation-positive, metastatic or unresectable, stage IIB to IV malignant melanoma.
Losing Nemo: Array pulls skin cancer NDA for binimetinib
Array BioPharma has yanked its NDA to the U.S. regulator for its late-stage melanoma candidate binimetinib after the agency told the biotech its phase 3 Nemo data wouldn’t cut it.
FDA Approval Sought for Lifileucel in Advanced Melanoma
A rolling biologics license application (BLA) seeking the approval of lifileucel (LN-44) in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy, has been submitted to the FDA.