The European Commission has approved Kisplyx (lenvatinib) for the treatment of adults with advanced renal cell carcinoma (RCC) after an accelerated assessment.
Eisai’s breakthrough orally-active drug is licensed in combination with Novartis’ mTOR inhibitor Afinitor (everolimus) in patients who have already been treated with at least one vascular endothelial growth factor (VEGF)-targeted therapy.
Its European approval is based on a phase II clinical trial showing the combination significantly extended progression-free survival in this patient population by 14.5 months, compared with the 5.5 months survival from Afinitor alone.
Under brand name Lenvima, Kisplyx was granted US marketing authorisation in May this year, the drug having received breakthrough and priority review status by the FDA.
Analysts are now suggesting that with Kisplyx’s approval in two key markets, plus its current global availability as a thyroid cancer treatment, the drug has blockbuster potential.
The prospects for Eisai’s drug over the coming years look particularly good, given RCC’s status as the most common kidney cancer.
RCC accounts for 2-3% of all cancer diagnoses and affects around 58,000 people in the US and 115,000 in Europe every year, and is associated with a five-year survival rate of only 12%.
Gary Hendler, Eisai’s chief commercial officer oncology business group, said: “This marketing authorisation underscores Eisai’s ongoing commitment to delivering and developing advances in the fight against cancer.
“We remain committed to exploring the potential of lenvatinib for people with cancer, their family and carers.”