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With FDA approval for its breast cancer blockbuster hopeful, Celcuity could ...
The FDA has approved Celcuity's gedatolisib (Revtorpyk) for hormone receptor-positive, HER2-negative breast cancer, positioning it as a potential blockbuster with efficacy superior to competing agents and plans to expand into first-line use and prostate cancer indications.
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The Wire takeaway
If you make companion diagnostics or biomarker tests for HR+/HER2- breast cancer, Revtorpyk's approval just created a new standard-of-care molecule that oncologists will now order tests to identify patients for. Your customer base expanded this week—call the labs and clinics using palbociclib-based regimens now.
Read the full story at fiercepharma.com →
Topics: Digital Health · fda-approval · breast-cancer · oncology-biotech · precision-medicine · drug-development · prostate-cancer