FDA Advisers Pan Pfizer’s PARP Drug; Sarepta to Resume Duchenne Study

FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

Gene Therapy Elevidys Slows Motor Decline In Boys With Duchenne, Phase 3 Trial Shows

Developed by Sarepta Therapeutics, Elevidys is a one-time, intravenous treatment that uses adeno-associated virus (AAV) technology to deliver a gene designed to produce a shortened form of the dystrophin protein, known as Elevidys micro-dystrophin, directly to skeletal muscle.

FDA adcomm votes unanimously against Pfizer's prostate cancer drug combo

The FDA’s Oncologic Drugs Advisory Committee voted 8-0 against a new indication for Pfizer’s Talzenna in combination with Xtandi for first-line treatment of adults with non-homologous recombination repair mutated (non-HRRm) metastatic castration-resistant prostate cancer. ...