U.S. FDA Approves FoundationOne CDx As A Companion Diagnostic For Astrazeneca's Truqap In Combination With Faslodex To Identify Patients With HR-Positive, HER2-Negative Advanced Breast Cancer
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The U.S. FDA has approved Foundation Medicine's FoundationOne CDx as a companion diagnostic for AstraZeneca's Truqap in combination with Faslodex for treating HR-positive, HER2-negative advanced breast cancer with specific alterations. This approval follows the positive results from the CAPItello-291 trial, which showed significant improvement in progression-free survival. FoundationOne CDx is the first FDA-approved test for this subset of breast cancer patients and is part of Foundation Medicine's portfolio of FDA-approved comprehensive genomic profiling tests.
November 20, 2023 | 5:04 pm
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POSITIVE IMPACT
AstraZeneca's Truqap, in combination with Faslodex, has received FDA approval for use in a specific advanced breast cancer treatment, which could potentially increase the drug's market and usage.
The FDA approval of Truqap for a specific breast cancer treatment is a positive development for AstraZeneca, likely leading to increased usage and market share for the drug in the short term.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
Foundation Medicine's FoundationOne CDx has been approved by the FDA as a companion diagnostic for AstraZeneca's Truqap, which could lead to increased demand for the test.
The FDA approval directly involves Foundation Medicine's diagnostic test, which is expected to see increased demand as it becomes a necessary step in identifying patients for Truqap treatment.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100