Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.

FDA Commissioner Margaret Hamburg says Genentech has failed to identify a subpopulation of patients in whom the clinical benefits outweigh the risks. The company says it will not appeal the indication’s withdrawal but will pursue a new study in breast cancer.

FDA Commissioner Margaret Hamburg says Genentech has failed to identify a subpopulation of patients in whom the clinical benefits outweigh the risks. The company says it will not appeal the indication’s withdrawal but will pursue a new study in breast cancer.