The US regulator has granted approval for a first-in-class oral tyrosine kinase inhibitor (TKI) developed by Japanese pharma major Takeda Pharmaceutical (TYO: 4502).
Exkivity (mobocertinib) is designed to target epidermal growth factor receptor (EGFR) Exon20 insertion mutations, and becomes the only approved oral therapy of this kind.
The approval from the US Food and Drug Administration covers second-line use of the therapy for adults with non-small cell lung cancer (NSCLC) which has this type of mutation, as determined by a genetic test.
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