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FDA Grants ‘Breakthrough Therapy’ Designation to Lenvatinib (Lenvima) for Treatment of Metastatic Renal Cancer

Tyrosine kinase inhibitor is currently approved for thyroid cancer

The FDA has granted “breakthrough therapy” status to the multiple-receptor tyrosine kinase inhibitor (TKI) lenvatinib (Lenvima, Eisai Inc.) for investigational use in patients with advanced or metastatic renal-cell carcinoma (RCC) who previously received vascular endothelial growth factor (VEGF)-targeted therapy.

Lenvatinib is currently indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). The treatment is not indicated for use in patients with metastatic RCC.

The FDA’s “breakthrough therapy” designation was established in 2012 to address unmet medical needs in the treatment of serious or life-threatening conditions. This designation is intended to expedite the development and review of drugs that have preliminary clinical evidence indicating that the treatment, alone or in combination, may demonstrate a substantial improvement over existing therapies and to help ensure that patients have access to them as soon as possible.

Lenvatinib received “breakthrough therapy” status based on results from a phase II open-label study involving 153 patients who were previously treated with a VEGF-targeted therapy. The patients were randomly assigned to receive lenvatinib and everolimus (LEN+EVE; 18 mg and 5 mg once a day), lenvatinib alone (LEN; 24 mg once a day), or everolimus (EVE; 10 mg once a day). Nearly all patients (99%) had received one VEGF-targeted therapy; 1% had received two VEGF-targeted therapies; and 18% had received immunotherapy. The results of this study were presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting.

LEN+EVE prolonged median progression-free survival compared with EVE (14.6 months vs. 5.5 months, respectively; P < 0.001). LEN alone also prolonged median PFS compared with EVE (7.4 months vs. 5.5 months, respectively; P = 0.048). LEN+EVE and LEN alone both improved the overall response rate compared with EVE (25.5% and 18.4% vs. 17.5%, respectively; P < 0.001 and P = 0.007). The median duration of response was longest with LEN+EVE (13.1 months) compared with LEN (7.5 months) and EVE (8.5 months).

Lenvatinib inhibits the kinase activities of VEGF receptors 1, 2, and 3. Lenvatinib also inhibits other receptor tyrosine kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors 1 through 4; the platelet-derived growth factor receptor alpha (PDGFR-alpha), KIT, and RET.

RCC is the most common type of kidney cancer, representing approximately 90% of cases in the U.S. Approximately 20% to 30% of patients with RCC have metastatic (stage IV) disease at diagnosis, and as many as 40% demonstrate metastasis after primary surgical treatment for localized RCC. The prognosis for these patients is poor, with 5-year survival rates ranging from 5% to 10%.

Sources: PR Newswire; July 28, 2015; and ASCO; 2015.

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