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, a letter from the regulator showed.
This deals a blow to the drug developer’s efforts to introduce its first marketed product, and 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.
The FDA in its Friday letter also 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.
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.
Tsai emphasized that unlike Tudriqev, Amtagvi is a one‑time therapy with more stronger data in a higher‑severity patient population and a clear first‑mover advantage supported by real‑world data.
Replimune’s shares were halted in afternoon trading.
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.
The drug’s previous rejection was during the tenure of the FDA’s then biologics unit chief Vinay Prasad, who departed the agency for the second time in February following internal tussles.
The recent high-profile dispute over the refusal to review Moderna’s influenza shot also unfolded when Prasad was at the agency.
Replimune did not immediately respond to a Reuters request for comment.
(Reporting by Padmanabhan Ananthan and Sruthi Narasimha Chari in Bengaluru; Editing by Jonathan Ananda and Devika Syamnath)
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