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FDA grants breakthrough drug designation to Lenvima for advanced RCC
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The FDA granted breakthrough drug designation to lenvatinib for the treatment of patients with advanced or metastatic renal cell carcinoma who received prior treatment with at least one VEGF-targeted therapy, according to a press release from the drug’s manufacturer.
Lenvatinib (Lenvima, Eisai Inc), a multiple receptor tyrosine kinase inhibitor, is currently approved for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
The FDA based its decision to grant the current breakthrough status in part on results of a phase 2 open label, multicenter study presented at the 2015 ASCO Annual Meeting in Chicago. The analysis included 153 patients who were previously treated with at least one VEGF-targeted therapy.
Researchers randomly assigned patients 1:1:1 to receive lenvatinib (24 mg daily), everolimus (Afinitor, Novartis; 10 mg daily) or lenvatinib plus everolimus (18 mg + 5 mg daily).
Ninety-nine percent of patients received one prior VEGF-targeted therapy, 1% received two prior VEGF-targeted therapies and 18% received prior immunotherapy treatment, according to the press release.
Researchers observed significantly prolonged PFS in patients who received lenvatinib alone (HR = 0.61; 95% CI, 0.38–0.98) or in combination with everolimus (HR = 0.4; 95% CI, 0.24–0.68) compared with patients who received everolimus alone.
Adverse events of note that occurred with lenvatinib included hypertension (73%), hemorrhagic events (35%), proteinuria (34%), renal impairment (14%) and cardiac dysfunction (7%).
Lenvatinib also has been granted FDA orphan drug status in various types of thyroid cancer.
"We are excited and honored that the FDA has granted breakthrough therapy designation to lenvatinib for patients with metastatic renal cell carcinoma," Kenichi Nomoto, PhD, president of the oncology product creation unit at Eisai Inc, said in a press release "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important additional treatment option to patients in need."