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Articles Authored by staff reporter

Sep 25, 2020

Blueprint Medicine's Ayvakyt Garners Conditional European Commission Authorization in GIST

In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.

Sep 25, 2020

BMS's Opdivo Prolongs Disease-Free Survival as Adjuvant Treatment for Patients With Bladder Cancer

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.

Sep 25, 2020

Blueprint Medicines to Pursue Ayvakit Approval in Cancer-Causing Mast Cell Disorder

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.

Sep 25, 2020

Biovica Files FDA 510(k) Submission for Breast Cancer Treatment Response Assay

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. 

Sep 25, 2020

Genetron, CStone Launch Clinical Trial to Develop CDx for Cancer Drug Avapritinib

Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation.

Sep 25, 2020

Natera Cancer Liquid Biopsy Test Coverage to Expand Under New Draft LCD

The draft LCD would cover the Signatera minimal residual disease test for several solid tumor types and indications, including immunotherapy response monitoring.

Sep 24, 2020

Calithera Biosciences Begins Phase II Lung Cancer Trial of Telaglenastat Plus Chemo, Immunotherapy

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.

Sep 24, 2020

Ideaya, Pfizer Expand Collaboration to Study IDE196, Xalkori

The companies will explore the IDE196 and Xalkori combination in solid tumors with GNAQ or GNA11 mutations, such as metastatic uveal melanoma.

Sep 23, 2020

Lantern Pharma, Fox Chase Partner on Pancreatic Cancer Drug, Search for Predictive Gene Signature

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.

Sep 23, 2020

FDA Accepts Pfizer's sNDA for Xalkori in Rare ALK-Positive Pediatric Leukemia Indication

The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.

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