Eisai’s Lenvima to be fast-tracked for kidney cancer

Eisai has filed its cancer drug Lenvima (lenvatinib) in Europe for use against advanced or metastatic renal cell carcinoma (RCC), where its review will be fast-tracked.

Lenvima is already approved for use against refractory thyroid cancer, but approval in kidney cancer could be a significant improvement on current standard therapy.

Phase 2 trials showed that when lenvatinib was added to standard treatment, Novartis’ Afinitor (everolimus) helped extend progression-free survival (PFS) by around 9 months on average.

These results have been enough for the US FDA to give the drug a Breakthrough Therapy Designation, where the drug has already been filed. Europe’s EMA granted its accelerated review in October.

The drug would be used as second line therapy in combination with Afinitor when patients have progressed on a VEGF-targeting treatment, such as Pfizer’s Sutent or GlaxoSmithKline’s Votrient.

Approval of Lenvima in this new indication in the US and Europe in 2016 would be great news for Eisai, which is trying to extend its presence in oncology. But BMS’ Opdivo gained FDA approval for advanced or metastatic RCC in November, and is likely to become the new standard in this setting.

“The news that Eisai has submitted this application is hugely positive, for both clinicians and patients alike. The current outlook for people with this aggressive cancer is poor, and therefore the potential of lenvatinib is very exciting indeed,” commented Dr Hilary Glen, Consultant Medical Oncologist, Beatson West of Scotland Cancer Centre, Scotland.

Patients given the drug as monotherapy also fared slightly better than those on everolimus alone, with a PFS improvement of just under two months.

The number of patients with renal cancer in Europe is estimated to be 115,000, and renal cell carcinoma comprises more than 90% of all malignancies of the kidney.

For patients with advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy such as Afinitor, but 5-year survival rates remain low.

Eisai is also conducting a global phase 3 study of lenvatinib in hepatocellular carcinoma as well as phase 2 studies in other tumour types such as endometrial carcinoma and biliary tract cancer.

Eisai says the data on overall survival (OS) suggest it is superior to Afinitor, but has not released details of its analysis. However, once approved, Lenvima is likely to be in the shadow of Bristol-Myers Squibb’s Opdivo. BMS’s immuno-oncology drug gained FDA approval as a monotherapy for second line use in RCC in November, and has already demonstrated a five month OS improvement over Afinitor (25 months average OS versus 19.6 months).

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