By Puyaan Singh
July 30 (Reuters) – The U.S. Food and Drug Administration’s panel of outside advisers on Thursday voted to back results from a trial studying Replimune’s drug for a type of skin cancer.
The FDA had declined to approve the drug, RP1, for a second time in April, citing reliance on a study without a control group, and sought more data demonstrating adequate evidence of 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.
Replimune is seeking accelerated approval for RP1 in combination with Bristol Myers Squibb’s Opdivo in advanced melanoma in patients whose tumors grew despite prior treatment.
The FDA, which is expected to decide on approval for the drug by August 2, has said flaws in the trial design make it difficult to determine whether tumor shrinkage was driven by RP1, and in its analysis said the response rate may be inflated.
While 10 experts voted ‘yes’ and 3 voted ‘no’, some of the positive voters still cast doubt on the study, with one member calling the data “really messy”.
“I voted yes with borderline no and really aligned with those other folks who are that on that level… there is some signal (in the data) and we should follow that signal,” said John Carrino, vice chairman, department of radiology and imaging at Hospital for Special Surgery.
The vote is not binding, but the FDA usually weighs its advisers’ views before deciding on approval.
“We look forward to continuing to work with the FDA as it completes its review,” said Replimune CEO Sushil Patel.
Hussein Tawbi, professor at The University of Texas MD Anderson Cancer Center, said the only other available therapy Iovance’s Amtagvi, which has an accelerated approval, for this population, is difficult to deliver broadly because patients must be fit enough for surgery.
Tawbi said, RP1 appeared “a lot safer, a lot easier.”
(Reporting by Puyaan Singh in Bengaluru; Editing by Shailesh Kuber)
