The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application to treat Opdivo (nivolumab) in patients with stage 2B or 2C melanoma that has been completely resected (surgically removed), according to Bristol Myers Squibb, the manufacturer of the immunotherapy agent.
Publications
FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma
Positive data from the phase 2b KEYNOTE-942 trial (NCT03897881) have led to the FDA to grant a breakthrough therapy designation to mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection, according to Moderna, Inc.
FDA Grants Breakthrough Therapy Designation to mRNA-4157/V940 Plus Pembrolizumab in High-Risk Melanoma
The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection.
Affordable treatment for recurrent melanoma
From 1 March 2023, Australians with recurrent melanoma will have a new treatment option subsidised by the Pharmaceutical Benefits Scheme (PBS).