U.S. FDA approves Larotrectinib, the first TRK inhibitor, for patients with advanced solid tumors harboring an NTRK gene fusion (for specialized target groups only)

First treatment with a tumor-agnostic indication at the time of initial FDA approval / Larotrectinib approved under the brand name Vitrakvi ® / 75% overall response rate (ORR) (95% CI, 61%, 85%) [22% complete response (CR) and 53% partial response (PR)] across various solid tumors in adults and children / Adverse events (AEs) of any grade observed in more than 20 percent of patients, regardless of attribution, included increased ALT (4 5%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%)
Source: Bayer Company News - Category: Pharmaceuticals Source Type: news