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FDA submission

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.

The guidance is meant to help provide the pharma industry, researchers, and IRBs with information to facilitate studies of oncology drugs for pediatric patients.

Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.