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Sanofi prostate cancer drug Jevtana approved in Europe

pharmafile | March 21, 2011 | News story | Sales and Marketing Jevtana, Sanofi-Aventis, TROPIC clinical trial, cabazitaxel, cancer drugs, chemotherapy, prostate cancer 

Sanofi-Aventis’ new chemotherapy treatment Jevtana has followed up on its US approval last year by receiving the green light in Europe.

Jevtana (cabazitaxel) has been approved in combination with the steroid prednisone by the European Commission to treat advanced second-line prostate cancer.

In the phase III TROPIC clinical study, this pairing was the first to show a significant survival benefit for patients with metastatic hormone-refractory prostate cancer (mHRPC).

“Jevtana in combination with prednisone/prednisolone reduced the risk of death by nearly one third and extended progression-free survival,” said Debasish Roychowdhury, head of Sanofi’s global oncology division.

More than 700 mHRPC patients receiving the combination, who had been previously treated with a docetaxel-containing treatment regimen, saw a median overall survival of just over 15 months.

In those receiving mitoxantrone plus prednisone it was only 12.7 months.

Around 300,000 new cases of prostate cancer appear in the European Union every year, making it the third most common cancer in men and the sixth biggest cancer killer.

“The European approval of Jevtana offers new hope for patients across Europe with limited treatment options should their disease progress following first-line therapy,” Roychowdhury added.

Hormone therapy is frequently the first treatment offered for mHRPC, with patients who no longer respond often receiving chemotherapy.

But some patients develop chemotherapy resistance, and their disease continues to progress. Before Jevtana, no available second-line treatment options were proven to provide a survival benefit in mHRPC patients.

Last year the performance of Jevtana in the US was one of Sanofi’s highlights, with the drug exceeding expectations in the first six months after its July approval there by bringing in 82 million euros in sales.

The EU decision applies to the 27 member states as well as Iceland, Lichtenstein and Norway. In addition to the US, Jevtana has also been approved in Israel and Brazil.

A semi-synthetic taxane, the drug works in a different way to docetaxel and paclitaxel, binding to tubulin and promoting tubulin’s assembly into microtubules and preventing disassembly.

Adam Hill

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