Categorized | Melanoma News, Regulatory

FDA Greenlights Nivolumab as an Adjuvant Melanoma Therapy

Source: Specialty Pharmacy Times, December 2017

Yesterday, nivolumab (Opdivo) was granted regular approval for the treatment of patients with melanoma whose disease spread to the lymph nodes or those with metastatic disease who have undergone resection, according to a press release.
“Today’s approval builds on our leadership in melanoma, offering physicians a new option with the potential to change the course of the disease through earlier intervention. Opdivo is the first PD-1 inhibitor approved as an adjuvant treatment for any cancer,” Johanna Mercier, head, US Commercial, Bristol-Myers Squibb, said in a company press release. “Our decision to study Opdivo versus Yervoy – an established standard of care with a proven survival benefit – represents our relentless pursuit to bring more effective treatments to patients.”
The new approval was granted based on improvements in recurrence-free survival (RFS), demonstrated in the CHECKMATE-238 trial. Included in the trial were 906 patients with completely resected stage 3b/c or stage 4 melanoma.
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