medwireNews: Larotrectinib has been recommended for approval by the EMA and is indicated for adult and pediatric patients with solid tumors harboring an NTRK gene fusion.
As such, it is the first drug to receive a positive decision from the Committee for Medicinal Products for Human Use on a histology-independent basis.
Specifically, the TRK inhibitor can be given to individuals who have no other treatment options for locally advanced, metastatic, or inoperable disease positive for an NTRK gene fusion.
Larotrectinib will be available either as on oral solution (20 mg/mL) or as capsules (25 and 100 mg).
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