The FDA has approved a new drug called Datroway for two different types of advanced cancer. First, it is for adults with a specific kind of non-small cell lung cancer that has an EGFR mutation and has spread or cannot be removed by surgery. These patients must have already tried an EGFR-targeted therapy and platinum chemotherapy. Second, it is for adults with a type of breast cancer that is hormone receptor positive and HER2 negative (scores IHC 0, 1+, or 2+ with negative ISH). This breast cancer must be advanced or spread, and patients must have already received hormone therapy and chemotherapy.
Datroway works by targeting a protein called Trop-2 on cancer cells and delivering a drug that interferes with cancer cell growth. The approval for lung cancer is based on early results showing tumor shrinkage, but continued approval depends on a larger study confirming benefit. For breast cancer, the approval is based on a trial showing improved outcomes.
This approval offers a new option for patients who have run out of standard treatments. However, it is not a cure, and side effects are possible. Patients should talk to their doctor to see if Datroway is right for their specific situation.