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

Pfizer disclosed that an experimental lung cancer drug it hoped could replace a widely used chemotherapy fell short in a clinical trialSTAT writes. Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year, Pfizer chief executive officer Albert Bourla said on an earnings call the drug “could be a driver of growth later this decade.” The company obtained the drug when it acquired Seagen for $43 billion in 2023. But the drug did not result in a statistically significant improvement in overall survival over docetaxel.

The U.S. Food and Drug Administration announced a pilot program to speed early-stage clinical trials, which it maintained will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the fieldSTAT tells us. The pilot comes as the agency, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. Acting FDA Commissioner Kyle Diamantas told reporters that the FDA will issue guidance reaffirming that a single, high-quality Phase 3 trial supported by confirmatory evidence is enough to allow drug approval.

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