STAT+: Pharmalittle: We’re reading about FDA reforming clinical trials, a Pfizer setback, and much more news

Pfizer announced on an unspecified date that its experimental lung cancer drug, sigvotatug vedotin, failed to demonstrate a statistically significant improvement in overall survival compared to docetaxel in a clinical trial. This outcome is a setback for Pfizer, which had acquired the drug through its $43 billion acquisition of Seagen in 2023 and had anticipated it could become a significant growth driver later this decade, as stated by CEO Albert Bourla. The U.S. Food and Drug Administration (FDA) also revealed a pilot program aimed at accelerating early-stage clinical trials, with the goal of reducing development timelines by six to 12 months. This initiative seeks to bolster U.S.-based trials and counter China's growing influence in the field. As part of its fiscal year 2027 budget request, the FDA is seeking congressional approval for a permanent, expedited process for the Investigational New Drug pathway. Acting FDA Commissioner Kyle Diamantas indicated that the agency will issue guidance confirming that a single, high-quality Phase 3 trial, supported by additional evidence, will be sufficient for drug approval.