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17-09-2021 | FDA | News

approvalsWatch

FDA approves mobocertinib for advanced NSCLC with EGFR exon 20 insertions

Author:
Hannah Kitt

medwireNews: Following accelerated approval by the US FDA, mobocertinib can now be used in previously treated patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations.

Mobocertinib (formerly TAK-788) is indicated for patients who have progressed on platinum-based chemotherapy, and the agency also approved a companion diagnostic assay – the Oncomine Dx Target Test (Life Technologies Corporation, Carlsbad, California, USA) – to detect the insertions.

Approval of the tyrosine kinase inhibitor was based on the results of Study 101, a phase 1/2 nonrandomized open-label trial that demonstrated an overall response rate of 28% and a median response duration of 17.5 months in this patient population.

The recommended daily dose of mobocertinib is 160 mg and it has a boxed warning for life-threatening QTc prolongation and Torsades de Pointes, as well as warnings for interstitial lung disease/pneumonitis, cardiac toxicity, diarrhea, and embryo–fetal toxicity.

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