Eusa Pharma receives EU approval for renal cell carcinoma therapy

Eusa Pharma has announced that its new cancer drug Fotivda has been approved by the European Commission.

The regulator has has licensed the tivozanib therapy for the first-line treatment of adult patients with advanced renal cell carcinoma, and for patients who are VEGFR and mTOR pathway inhibitor-naive following disease progression after prior cytokine therapy.

This approval was based on data from the phase III trial TiVO-1, which demonstrated the efficacy and tolerability of Eusa Pharma's drug compared to a currently available comparator VEGFR-TKI treatment.

Fotivda demonstrated superior progression-free survival benefits compared to the rival therapy, as well as an improved side effect profile.

Lee Morley, Eusa Pharma's chief executive officer, said: "Tivozanib has the potential to become an important new first-line therapy and the EU licensing is a great achievement for the Eusa team."

The company will now work with the relevant health authorities to make tivozanib available to patients across Europe as quickly as possible.

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