The Food and Drug Administration could soon decide on whether to make AstraZeneca and Daiichi Sankyo’s drug Enhertu available for any solid tumor with a specific genetic signature.
The partners on Monday said the FDA is reviewing their request to approve Enhertu for adults with unresectable or metastatic tumors that express the protein HER2. Patients who previously received another therapy or who have “no satisfactory alternative” treatment option would be eligible, the companies said.
