FDA approved Ibtrozi (taletrectinib) for ROS1-Positive Non-Small Cell Lung CancerFDA approved New Once-Daily Pill for a Type of Lung Cancer

Taletrectinib is a kinase inhibitor. The label states Ibtrozi is a kinase inhibitor indicated for ROS1-positive NSCLC; further mechanistic detail is not reported in the provided label text.

Ibtrozi is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Select patients based on the presence of ROS1 rearrangement(s) in tumor specimens. An FDA-approved test to detect ROS1 rearrangement(s) for selecting patients for treatment with Ibtrozi is not currently available.

The recommended dosage is 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before and 2 hours after taking Ibtrozi) until disease progression or unacceptable toxicity. Take at approximately the same time each day. Swallow capsules whole; do not open, chew, crush, or dissolve. Avoid food or drink containing grapefruit during treatment. Minimize sun exposure and use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. If a dose is missed, take the next dose at its scheduled time the following day. If vomiting occurs after a dose, take the next dose at its scheduled time the following day. Dose reductions: first reduction to 400 mg once daily; second reduction to 200 mg once daily; permanently discontinue in patients unable to tolerate 200 mg once daily. Before initiating, evaluate liver function tests (ALT, AST, bilirubin), electrolytes, ECG, and uric acid.

Trial data not available in label.

Dosage modifications are specified for hepatotoxicity, ILD/pneumonitis, QTc interval prolongation, hyperuricemia, creatine phosphokinase elevation, and other adverse reactions. Hepatotoxicity: for Grade 3 ALT/AST elevation (>5 to 20 times ULN), withhold until recovery to Grade 1 or baseline; if resolved within 6 weeks, resume at a reduced dose; if unresolved after 6 weeks, permanently discontinue. For Grade 4 (>20 times ULN), withhold and resume at reduced dose if resolved within 6 weeks, otherwise permanently discontinue; on recurrence, permanently discontinue. For ALT or AST at least 3 times ULN with concurrent total bilirubin at least 2 times ULN (without cholestasis or hemolysis), permanently discontinue. ILD/pneumonitis: Grade 1, withhold until recovery to Grade 0 or baseline; if resolved within 6 weeks, resume at same dose; recurrence requires permanent discontinuation. Grade 2, withhold until recovery; if resolved within 6 weeks, resume at reduced dose; recurrence requires permanent discontinuation. Grade 3 or 4, permanently discontinue. QTc prolongation: Grade 2 (481 to 500 msec), withhold until recovery to Grade 1 or baseline, correct electrolytes and/or change concomitant medications, resume at same dose. Grade 3 (at least 501 msec or increase greater than 60 msec from baseline), withhold until recovery, correct electrolytes and/or change concomitant medications, resume at reduced dose. Grade 4 (torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia), permanently discontinue. Hyperuricemia: Grade 3 or 4, withhold until improvement of signs or symptoms; resume at same or reduced dose level or permanently discontinue. CPK elevation: greater than 5 times ULN, withhold until recovery to baseline or at most 2.5 times ULN, then resume at same dose; greater than 10 times ULN or second occurrence of greater than 5 times ULN, withhold until recovery to baseline or at most 2.5 times ULN, then resume at reduced dose. Contraindications are not reported in the provided label text.

The label positions Ibtrozi as an oral kinase inhibitor for adults with locally advanced or metastatic ROS1-positive NSCLC, selected by presence of ROS1 rearrangement(s). Treatment continues until disease progression