The FDA has granted Eisai’s promising cancer drug Lenvima breakthrough therapy designation for renal cell carcinoma.

The designation is based on the results of a Phase II trial that showed that Lenvima plus Novartis’ Afinitor (everolimus) “significantly” extended progression-free survival (PFS) compared to Afinitor alone. Lenvima as a monotherapy was also shown to extend PFS compared to Afinitor.

The drug has already been launched in several countries as a treatment for refractory thyroid cancer – for which it received orphan drug designation in the US, the UK and Japan – and it is also being trialled in several other tumour types including hepatocellular carcinoma, endometrial carcinoma and non-small cell lung cancer.

Additionally, Eisai has teamed up with Merck to test the drug in combination with the latter firm’s cancer immunotherapy Keytruda (pembrolizumab).

The drug is a multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of several receptors involved in tumour proliferation.

Renal cell carcinoma comprises more than 90% of all malignancies of the kidney and is thought to affect 338,000 people worldwide.