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23-08-2019 | FDA | News

approvalsWatch

Entrectinib gains two indications in USA

medwireNews: Entrectinib has become the third drug to receive a tumor-agnostic approval by the US FDA, and has additionally been approved for ROS1 mutation-positive non-small-cell lung cancer (NSCLC).

As per the decision, the multitargeted kinase inhibitor – which inhibits TRK, ROS1, and ALK – can be prescribed for pediatric patients aged at least 12 years and adults who have a solid cancer harboring an NTRK fusion. Patients are required to have inoperable or metastatic disease, and need to have progressed on previous therapy or be ineligible for standard therapeutic options.

The approval is based on a pooled analysis of the ALKA-372-001, STARTRK-1, and STARTRK-2 trials comprising 54 participants, including those with sarcoma, mammary analogue secretory carcinoma, and thyroid cancer.

Entrectinib can now also be given to adult patients with metastatic NSCLC harboring ROS1 mutations; evidence for this indication comes from the same three trials, which included 51 NSCLC patients.

The recommended dose for adults is 600 mg/day, regardless of the indication, but the dose should be calculated based on body surface area for pediatric patients with NTRK fusion-positive tumors.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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