FDA Approves Ibtrozi for ROS1+ Advanced Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration had approved Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

The efficacy of the treatment was evaluated in those with locally advanced or metastatic ROS1-positive NSCLC who were enrolled onto two multicenter, single-arm, open-label trials: TRUST-I and TRUST-II.

Among treatment-naive patients, the overall response rate was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of responders, respectively, experiencing a duration of response of at least 12 months. Among patients who had previously received a ROS1 tyrosine kinase inhibitor, the overall response rate was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83% of responders, respectively, having a duration of response of at least 6 months.

The efficacy population included 157 patients (103 in TRUST-I and 54 in TRUST-II) who were naive to ROS1 tyrosine kinase inhibitors and 113 patients (66 in TRUST-I and 47 in TRUST-II) who had received one prior ROS1 tyrosine kinase inhibitor. Some patients may have received prior chemotherapy for advanced disease. The major efficacy outcomes were confirmed overall response rate and duration of response, assessed by blinded independent central review using RECIST version 1.1.

This application was reviewed through the FDA’s expedited programs for serious conditions, including priority review, breakthrough therapy designation and orphan drug designation. These programs help speed up the development and review of promising treatments for serious or rare diseases.

Prescribing Warnings and Recommended Dose

Ibtrozi may cause serious side effects, including liver problems, lung inflammation (pneumonitis), changes in heart rhythm (QTc prolongation), high uric acid levels (hyperuricemia), muscle pain with muscle damage, bone fractures and harm to an unborn baby. Patients should talk with their care team about these risks before starting treatment.

The recommended dose is 600 milligrams taken by mouth once daily on an empty stomach. Patients should avoid eating for at least two hours before and after each dose. Treatment continues until the cancer worsens or side effects require stopping or adjusting the dose.

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