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Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK ...
Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK ...
The indication is specifically for those patients who have solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion that are without a known acquired resistance mutation, are ...
The firm submitted data from a registrational study showing the drug's activity in adult and adolescent patients with NTRK fusion-positive solid tumors.
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) o ...
It is poised to redefine the approach to treatment for newly diagnosed fibrosarcoma and other solid tumors with the NTRK gene fusion, potentially reducing or eliminating the need for these ...
The FDA has fully approved larotrectinib for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion.
Bayer's Vitrakvi receives full FDA approval based on solid tumor data showing sustained efficacy in NTRK fusion-positive patients.
The U.S. Food and Drug Administration (FDA) has granted full approval to Vitrakvi (larotrectinib) for the treatment of adult ...
U.S. FDA Grants Full Approval of VITRAKVI® (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive ...
The 2018 accelerated approval of Vitrakvi was converted to full approval based on results from three trials in adult and pediatric patients.