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FDA grants priority review to Lenvima for advanced renal cell carcinoma
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The FDA granted priority review to lenvatinib for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma, according to a press release from the drug’s manufacturer.
This indication of lenvatinib (Lenvima, Eisai) is intended for use in combination with everolimus following one prior VEGF-targeted therapy. Lenvatinib also previously received breakthrough therapy designation for this indication.
“With the FDA's acceptance of this supplemental application, we are one step closer to potentially providing the first tyrosine kinase and mTOR inhibitor combination therapy to patients with unresectable advanced or metastatic renal cell carcinoma,” Kenichi Nomoto, PhD, president of the Oncology Product Creation Unit at Eisai, said in the release. “We look forward to working with the FDA over the coming months as it considers this potential new option for patients with advanced [renal cell carcinoma].”
Lenvatinib is currently FDA approved for the treatment of patients with differentiated thyroid cancer whose disease progressed after receiving radioactive iodine therapy.