FDA Grants Eisai’s Lenvima Breakthrough Therapy Designation for Kidney Cancer

The FDA has granted Eisai’s Lenvima breakthrough therapy designation for the treatment of renal cell carcinoma.

The breakthrough designation was based on a Phase 3 trial that compared Lenvima (lenvatinib) plus Novartis’ cancer drug Afinitor (everolimus) with Afinitor alone. The combination significantly extended progression-free survival versus just Afinitor, Eisai says. Lenvima also bested Afinitor when used alone.

Currently, no combination therapy is approved for kidney cancer in the U.S., Europe or Japan.

Lenvima is available as an orphan product in all three jurisdictions to treat refractory thyroid cancer. Eisai is also studying the drug’s benefits in treating liver cancer, uterine cancer and non-small cell lung cancer. — Kellen Owings