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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.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
The agency granted the NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.
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.
The FDA has granted priority review to the supplemental biologics license application for the second tissue-agnostic indication of Keytruda.
The company announced that it is planning to submit an NDA for the drug in RET-mutant medullary thyroid cancer.
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.