You may find more results for this query on our sister sites: GenomeWeb and 360Dx.
In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.
The firm said that adjuvant nivolumab had benefitted patients regardless of PD-L1 expression, and that the company will submit the data to regulatory agencies.
The company will seek FDA approval in advanced systemic mastocytosis, a disorder that can turn into cancer in 7 percent of children and 30 percent of adults.
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.
Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation.
The draft LCD would cover the Signatera minimal residual disease test for several solid tumor types and indications, including immunotherapy response monitoring.
The randomized trial will assess the glutaminase inhibitor plus standard-of-care versus standard-of-care alone in patients with KEAP1- or NRF2-mutated tumors.
The companies will explore the IDE196 and Xalkori combination in solid tumors with GNAQ or GNA11 mutations, such as metastatic uveal melanoma.
The company hopes the collaboration will allow it to home in on a molecularly defined population of patients likely to benefit from its targeted agent LP-184.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.