Replimune Skin Cancer Drug Rejected Again by FDA
Why it matters: The rejection impacts **Replimune Group's** ability to bring its advanced skin cancer treatment to market.
- Replimune Group's experimental skin cancer drug, an engineered virus, was rejected for a second time by the FDA.
- The FDA's decision is seen as a potential consequence of shifting standards under Vinay Prasad, the new head of biologics, who has advocated for stricter drug approval criteria.
- The drug was initially rejected in July, two months after Prasad's appointment, signaling a possible change in the agency's approach to approving treatments.
The FDA has again rejected Replimune Group's experimental skin cancer treatment, an engineered virus designed to stimulate the immune system against melanoma. This decision reinforces a stricter regulatory stance at the agency, particularly following the appointment of Vinay Prasad as head of biologics, who has previously criticized approvals based on limited data.
