Knives out at ODAC with vote against accelerated approval for Spectrum lung cancer drug
Following the release of scathing briefing documents earlier this week, FDA reviewers continued to lambast Spectrum Pharmaceuticals’ potential lung cancer drug poziotinib, and outside advisors on ODAC voted 9-4 against its benefit-risk profile.
FDA presenters made clear on Thursday that there are major issues with the poziotinib application, including its efficacy in the pivotal trial, not being an improvement over currently available therapies (a requirement for an AA), the high rate of toxicity, inadequate dose optimization (a problem initially raised by FDA in 2017), and the delayed confirmation of benefit considering the company has yet to enroll any patients in its proposed confirmatory study.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.