Today, the U.S. Food and Drug Administration approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).
Regulatory
FDA Approves Lifileucel for Unresectable or Metastatic Melanoma
Adjuvant checkpoint inhibitor therapy is the standard of care for resectable melanoma. Although many patients derive lasting benefit from the treatment, a substantial number experience disease recurrence.
SkylineDx Announces Grant of European Patent and Advances in Melanoma Diagnosis and Treatment
ROTTERDAM, Netherlands and SAN DIEGO, Jan. 9, 2024 /PRNewswire/ — SkylineDx, an innovative diagnostics company focused on the research and development of molecular diagnostics, is excited to announce that the European Patent Office (EPO) has granted European Patent No. 3827101, marking a groundbreaking advancement in the field of cancer diagnostics and personalized treatment.
Bristol Myers Squibb’s Opdualag recommended by NICE for advanced melanoma
Bristol Myers Squibb’s (BMS) Opdualag (nivolumab-relatlimab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line treatment of advanced melanoma in patients aged 12 years and older.