Trials & Tribulations

San Antonio Breast Cancer Symposium 2022 tackled big obstacles, recommended solutions for breast cancer progress
Trials & Tribulations

San Antonio Breast Cancer Symposium 2022 tackled big obstacles, recommended solutions for breast cancer progress

To provide a roadmap for accelerating progress against breast cancer over the next 10 years, an expert panel was convened at the 2022 San Antonio Breast Cancer Symposium to identify the biggest obstacles hindering our ability to cure breast cancer and to propose transformative solutions to address these obstacles.
Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”
FreeTrials & Tribulations

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).