FDA Gives Guidance on Development of Breast Cancer Drugs
The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
FDA published final guidance on June 17, 2021 for the development of treatments for breast cancer. The guidance offers recommendations for including premenopausal women in clinical trials of breast cancer drugs and biological products. The agency states in the guidance that menopausal status should not be the reason for exclusion from breast cancer clinical trials, and women with adequate estrogen suppression and postmenopausal women should be eligible for inclusion in clinical trials for drugs or combinations manipulating the hormonal axis.
The guidance does not address fertility and fertility preservations issues when treating premenopausal women with breast cancer. The agency recommends that a gynecologist be consulted during trial planning and monitoring.
Source: FDA
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
November 11th 2024With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.
