Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi
The latest drug development news and highlights from our US FDA Performance Tracker.
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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.
Erleada is ninth product known to be using US FDA’s Real-Time Oncology Review pilot program, as shown in our comprehensive chart.
Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.