US regulators are undertaking an accelerated review of Eisai’s lenvatinib as a treatment for patients with kidney cancer.
Eisai is seeking to expand the drug’s treatment scope to include patients with unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with Novartis’ Afinitor (everolimus) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
The US Food and Drug Administration has already awarded lenvatinib ‘breakthrough therapy’ status for this indication, signifying that the drug could potentially offer a substantial improvement over existing therapies.
Around 61,000 new cases of kidney cancer are diagnosed every year in the US. The prognosis for patients with metastatic RCC is poor, and additional treatment option are urgently needed, said Eisai, noting that FDA approval would give patients access to the first tyrosine kinase and mTOR inhibitor combination therapy for the disease.
The drug has also been filed in Europe for kidney cancer, based on Phase II showing that it significantly extended progression-free survival (PFS) when added to Afinitor; those given the combination regimen experienced a median PFS of 14.6 months versus 5.5 months for those taking everolimus alone.
Lenvatib is already on the US market under the brand name Lenvima for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.