Novartis receives CHMP recommendation for Votubia

Novartis has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of its cancer therapy Votubia.

The European Medicines Agency committee has endorsed the drug for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications, but who do not require immediate surgery.

Data from the phase III clinical study Exist-2 demonstrates that the treatment is able to deliver significantly improved efficacy compared to placebo, thanks to its ability to inhibit mTOR, a protein implicated in many tumour-causing pathways.

If approved, Votubia would become the first therapy available in the EU for this indication.

Herve Hoppenot, president at Novartis Oncology, said: "Today's positive CHMP opinion for Votubia is important for patients in the EU with TSC, as renal angiomyolipoma is among the most difficult-to-treat manifestations of this debilitating disease."

This comes after the company launched the EU-approved breast cancer drug Afinitor in the UK last week.