The submission follows a clinical validation study of the test that analyzed data from samples collected from 400 US and Canadian patients with advanced HR+ breast cancer.
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.
At ASCO, Blueprint presented positive data on its RET inhibitor pralsetinib across a range of cancers and in a call with investors discussed regulatory plans in lung and thyroid cancers.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
