By Padmanabhan Ananthan and Sruthi Narasimha Chari
April 10 (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Replimune’s drug for advanced skin cancer, citing insufficient data from studies, sending its shares down 58% in extended trading.
The rejection is the second consecutive setback for experimental melanoma drug Tudriqev after the U.S. regulator declined to approve it last year, citing issues in clinical trials and inadequate evidence of effectiveness.
Replimune CEO Sushil Patel said the company has no choice but to eliminate jobs and substantially scale back its U.S.-based manufacturing operations as a result of the decision.
The FDA, in its Friday letter, raised concerns about the drug’s reliance on a single‑arm study and said Replimune must provide data from a well‑controlled trial demonstrating adequate evidence of effectiveness.
The company said it disagreed with the FDA about whether the data set was sufficient for approval, and added that the agency appeared to have contradicted its positions expressed at a meeting in September.
However Replimune will initiate a late-stage trial to satisfy the regulatory requirement of a confirmatory study for accelerated approval.
Tudriqev is an oncolytic immunotherapy, a type of treatment that uses a genetically modified herpes virus to selectively detect and destroy cancer cells.
Jefferies analyst Andrew Tsai said the decision on Tudriqev makes “one less competitor” in the near-term for Iovance’s Amtagvi, which was approved by the FDA for the same condition in 2024.
The FDA’s latest so-called complete response letter said that data from two studies were not strong enough to support approval of the treatment in combination with Bristol Myers Squibb’s Opdivo for adults with advanced melanoma.
Advanced melanoma is a serious form of skin cancer that rapidly spreads to other parts of the body, making it harder to treat.
(Reporting by Padmanabhan Ananthan, Sruthi Narasimha Chari and Christy Santhosh in Bengaluru; Editing by Jonathan Ananda, Devika Syamnath and Anil D’Silva)
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