ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men
Executive Summary
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.
You may also be interested in...
Keeping Track: Turalio, Nubeqa And Accrufer Mark Trio Of Novel Drug Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling
Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.
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.