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Metastasis-Free Survival Endpoint Spreads To Labeling With US FDA Approval Of J&J's Erleada

Executive Summary

Apalutamide, the first drug approved to treat non-metastatic castration-resistant prostate cancer, will also be the first NDA to have clinical summary report information made public under an FDA pilot program to increase transparency.

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US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time

FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.

US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time

FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.

ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men

Exploratory analysis suggests cancer patients with poorer baseline status can be enrolled in clinical trials without endangering registration prospects for the drug. Older prostate cancer patients derived a similar benefit to younger patients in metastasis-free survival with androgen-receptor inhibitors, FDA researchers found in an exploratory subgroup analysis of three registrational trials.

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