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FDA Re-examines Skin Cancer Drug After White House Push
3 Jun
Summary
- Replimune to seek approval for experimental skin cancer drug again.
- White House reportedly urged FDA to reconsider drug rejections.
- Drug seeks approval for advanced melanoma in combination therapy.
Replimune is preparing to resubmit its application for regulatory approval of its experimental skin cancer drug, RP1, in the coming days. The U.S. Food and Drug Administration (FDA) had previously rejected the drug's application twice. The most recent rejection occurred in April, with the FDA citing the reliance on a single-arm study and requesting data from a well-controlled trial.
Following the latest rejection, Replimune engaged with the White House. Reports indicate that the White House then urged health officials to re-evaluate the FDA's prior decisions regarding the advanced melanoma treatment. The company is seeking approval for RP1 when used in combination with Bristol Myers Squibb's immunotherapy drug, Opdivo, to treat advanced melanoma.
The FDA has indicated that it will expedite the review of Replimune's resubmission. Analysts expressed optimism about the reapplication but remained cautious, suggesting that changes in FDA leadership might be a key factor in the regulator's potential shift in stance.
