The new accelerated approval for the TKI was based on the overall response rate in 48 patients.
for all locally advanced, unresectable, or metastatic solid tumors with angene fusion that have progressed after initial treatment or that have no satisfactory alternative therapies.in November 2023 for locally advanced or metastaticgene fusions are genetic abnormalities wherein part of thegene fuses with an unrelated gene. The abnormal gene can then produce an oncogenic protein. Although rare, these mutations are found in many cancer types.
The approval, for adult and pediatric patients aged 12 years or older, was based on the single-arm open-label TRIDENT-1 trial in 88 adults with locally advanced or metastaticIn the 40 patients who were TKI-naive, the overall response rate was 58%, and the median duration of response was not estimable. In the 48 patients who had a TKI previously, the overall response rate was 50% and median duration of response was 9.9 months.
Labelling warns of central nervous system reactions, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with
Genomic Medicine Otolaryngology ENT Specialty Head And Neck Surgery ENT Speciality Dentistry Oral Health Oral Medicine Dental Health Dental Oral Healthcare Oral Health Care Toxicology Toxicity Poisoning Toxins Lung Cancer Lung Carcinoma Cancer Of The Lung Small Cell Lung Cancer Small-Cell Lung Cancer Oat Cell Lung Cancer SCLC Biologic Therapy Biologics
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