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Entrectinib is authorized for advanced NTRK fusion-positive solid tumors with no alternative treatment, and ROS1-positive NSCLC patients.
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.
The company is employing Guardant360 in a Phase III trial assessing the efficacy of the drug both in a larger population and in women who test positive for ESR1 mutations.
Idecabtagene vicleucel is a B-cell maturation antigen-directed CAR T-cell immunotherapy being developed as a treatment for patients with relapsed and refractory multiple myeloma.
Merck announced that the FDA accepted supplemental biologic license applications for the checkpoint inhibitor for early- and later-stage triple-negative breast cancer.
The dose-finding study will now enroll up to 30 patients with sarcomas characterized by gene rearrangements similar to Ewing sarcoma.
Repare will test RP-3500 as a monotherapy and in combination with PARP inhibitor talazoparib in patients who were identified as likely to respond through its SNIPRx platform.
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.