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Breaking news on Precision Oncology business, policy & funding.
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.
The commission took the earlier CHMP recommendation to approve the treatment based on the positive results from the Phase III SOLAR-1 trial.
In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
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.