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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel

Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.

We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging

With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.

Setback For Athenex, Hanmi As CRL Requests New Trial

Hanmi partner Athenex has had a US complete response letter for its oral paclitaxel plus encequidar product for the treatment of metastatic breast cancer, amid concerns of safety risks associated with an increase in neutropenia-related sequelae. While the decision marks another setback for Hanmi in the US, Athenex is aiming to resolve the issues.

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