The U.S. Food and Drug Administration (FDA) has agreed that Opdivo (nivolumab) can be used as an adjuvant treatment of certain melanoma patients, to prevent their cancer from returning.
The approval will allow patients with lymph node involvement, or those with metastatic melanoma who have had a complete resection, to use Opdivo as a way to prevent relapse.
“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,” Johanna Mercier, head, U.S. Commercial at Bristol-Myers Squibb, said in a press release.
“Opdivo is the first PD-1 inhibitor approved as an adjuvant treatment for any cancer,” she added.
The FDA’s decision builds on data from the Phase 3 CheckMate 238 trial (NCT02388906). The study compared the ability of Opdivo and Yervoy (ipilimumab) to prevent recurrence of melanoma after surgery.
CheckMate 238 showed that patients with advanced melanoma who received Opdivo after surgery had significantly better recurrence-free survival compared to Yervoy. At 18 months, 66.4 percent of Opdivo-treated patients had not relapsed, compared with 52.7 percent for Yervoy.
This translated to a 35 percent lower risk of melanoma recurrence with Opdivo treatment.
Patients with different types of molecular melanoma subtypes, including those with BRAF mutations, benefited equally well from the treatment.
“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,” said Mercier.
Opdivo, acting as a checkpoint inhibitor by targeting PD-1, is, so far, the only drug in this class approved for use as an adjuvant treatment for melanoma or other cancers.
“When melanoma has been removed surgically, physicians and patients alike sometimes struggle with the idea of further adjuvant treatment because the disease is no longer detectable, even though it may be likely to return,” said Jeffrey S. Weber, MD, PhD, deputy director of the Perlmutter Cancer Center at NYU Langone Health, and professor of medicine at NYU School of Medicine.
“Immuno-Oncology has transformed the treatment of metastatic melanoma and many other cancers over the last decade, and we are now extending the use of novel agents to help prevent the recurrence of melanoma,” Weber added.