World briefing
FDA grants accelerated approval to breast cancer drug Etcamah
The FDA has expanded treatment options for adults with advanced breast cancer by granting accelerated approval to Etcamah.
The FDA has approved Etcamah, a breast cancer drug that works against resistant tumors. Patients receiving it in clinical trials went a median of 16 months before their cancer worsened.
The treatment is intended for adults with HR-positive, HER2-negative breast cancer that has spread beyond the breast or into nearby tissue. Its use is specific to that patient group.
The FDA has also authorized Guardant360 CDx, a blood test that detects an ESR1 gene change. The test can flag resistance before a scan, allowing an earlier switch to Etcamah.
Whether the early-switch strategy helps patients live longer overall remains unresolved. Regulators are still awaiting mature data to distinguish an overall survival benefit from a delay in cancer progression.
Potential serious side effects include heart arrhythmia. Doctors and patients will need to monitor those risks carefully and weigh them against the benefits of the treatment approach.