The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.
FDA released guidance in August 2020 on the development and labeling of treatments for male patients with breast cancer. According to FDA, due to the rare nature of breast cancer in males, they have been excluded from clinical trials of breast cancer drugs.
The guidance recommends that both males and females should be included in eligibility criteria for clinical trials. “FDA does not intend to consider low expected accrual rates of male patients with breast cancer to be a sufficient scientific rationale for excluding them from a clinical trial,” the guidance states. In addition, the guidance states, “sponsors should conduct nonclinical general toxicology studies in male and female animals” when males are included in clinical trials for breast cancer treatments.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.