The approval is based on the results from the Phase III IMspire150 study, in which patients treated with the three-drug combination had an improvement in progression-free survival.
Merck announced that the FDA accepted supplemental biologic license applications for the checkpoint inhibitor for early- and later-stage triple-negative breast cancer.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
