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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.
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