The Food and Drug Administration on Friday approved a new, targeted breast cancer drug for patients who become resistant to hormone therapy. File Photo by Jim Lo Scalzo/EPA-EFE
Sept. 4 (UPI) — The Food and Drug Administration on Friday approved a new, targeted breast cancer drug for patients who become resistant to hormone therapy.
The drug, camizestrant, was approved under the FDA’s accelerated approval program.
It acts on ESR1 mutations, which are acquired resistances that tumors may develop during treatment for metastatic breast cancer.
“Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment,” acting FDA Commissioner Kyle Diamantas said in a statement. “We owe them every weapon in our arsenal.”
“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said, “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.”
“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing,” he added.
“But additional evidence is needed to confirm clinical benefit.”