The biomarker-driven, multi-arm, multi-drug registration trial is expected to get under way in March 2014 with five drugs from different sponsors. With the promise of greater speed and efficiency in patient enrollment and late-stage development, it is being viewed as a potential model for other cancer settings.

Sponsor’s assertion of a ‘floor effect’ cannot explain the lack of difference versus placebo on clinical endpoints, and there is no evidence that assessed biomarkers are reasonably likely to predict clinical benefit, agency says. Although advisory committee will focus primarily on efficacy, FDA also cites concerns about ‘grossly deficient’ product quality information.

Abrysvo is recommended for use in pregnant people 32-36 weeks gestation if administered from September to January. For infants whose mothers were not vaccinated in this window, nirsevimab is recommended for prevention of respiratory syncytial virus infection.