- US FDA advisers voted to back results from a trial studying Replimune's drug for a type of skin cancer.
- The FDA panel voted 10-3 in favor of Replimune's melanoma treatment after a contentious meeting.
- Replimune is seeking accelerated approval for RP1 in combination with Bristol Myers Squibb's Opdivo in advanced melanoma patients.
- Despite the positive vote, some experts expressed doubts about the study design, with one member calling the data "really messy."
- The FDA is expected to decide on approval for the drug by August 2.
- Replimune's first two applications for the melanoma therapy were rejected by the FDA.
- The regulatory saga for this treatment has stretched nearly two years.
- Earlier this week, a critical FDA analysis of the company’s results triggered a more than 30% drop in its stock price.
The U.S. FDA advisory panel's 10-3 vote on Thursday endorses Replimune's RP1 for advanced melanoma, a significant step after two previous rejections.3
The FDA had previously expressed concerns about the trial's design, stating it was difficult to ascertain the drug's effectiveness.
"This is a very hard to treat patient population... these patients then got RP1 and had some CRs (complete responses)... data does show... these patients are getting benefit from RP1," said Melinda Yushak, a medical oncologist at Emory University.
Despite the positive vote, some experts voiced skepticism, with one describing the data as "really messy."
John Carrino, vice chairman at the Hospital for Special Surgery, noted, "I voted yes with borderline no... there is some signal (in the data) and we should follow that signal."
The FDA is expected to make a decision by August 2, 2023, and while the advisory vote is not binding, it typically influences the agency's final decision.
Replimune's CEO, Sushil Patel, expressed optimism, stating, "We look forward to continuing to work with the FDA as it completes its review."
The recommendation comes amid a regulatory saga that has seen the drug's stock price drop over 30% following critical FDA analyses.7
Hussein Tawbi from MD Anderson noted that RP1 appears "a lot safer, a lot easier" compared to existing therapies, which are challenging to deliver broadly.
The panel's backing may pave the way for RP1's potential approval, offering hope to patients with limited treatment options.
“A critical FDA analysis this week triggered a more than 30% drop in Replimune's stock and said the drug's response rate may be inflated; one panelist called the data 'really messy.' Replimune CEO Sushil Patel said the company looks forward to continuing to work with the FDA as it completes its review.”
WSJ
