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Latest From Sue Sutter
Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.
Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.
The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.
US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.
Criticism of Novartis/Avexis’s controversial lottery style managed access program for Zolgensma has come largely from Europe, while other countries in Latin America and Asia have been far more receptive.