The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab (Opdivo; Opdualag) for use in the frontline treatment of adult and adolescent patients aged 12 years of age and older with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.
Regulatory
Nivolumab/Relatlimab Combo for Treatment of Unresectable or Metastatic Melanoma
The European Commission based its approval of nivolumab/relatlimab for patients with a PD-L1 expression of less than 1% on the results of the phase 2/3 RELATIVITY-047 trial.
FDA Grants Fast Track Designation to KIN-2787 for Select Stage IIB to IV Malignant Melanoma
The FDA has granted a fast track designation to KIN-2787 for use as a potential therapeutic option in patients with BRAF class II or III alteration–positive and/or NRAS mutation–positive, metastatic or unresectable, stage IIB to IV malignant melanoma.
NICE recommends MSD’s pembrolizumab to treat melanoma
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.