Teva Pharmaceutical Industries has obtained approval from the European Commission for an indication extension of Trisenox (arsenic trioxide).

The extension is for newly diagnosed, low-to-intermediate-risk, acute promyelocytic leukaemia (APL) in combination with retinoic acid.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

APL is a rare and aggressive type of acute leukaemia that can kill within hours or days if left untreated.

In combination with retinoic acid, Trisenox has shown a 99% overall survival rate with almost no relapses after more than four years of median follow-up.

Teva global specialty medicines president and CEO Rob Koremans said: “Teva is committed to providing wider access to high-quality medicines to ensure more people can benefit from the treatments they need.

See Also:

"We’re very pleased by this decision of the European Commission, and we look forward to offering a chemotherapy-free treatment option for all newly diagnosed APL patients."

“We’re very pleased by this decision of the European Commission, and we look forward to offering a chemotherapy-free treatment option for all newly diagnosed APL patients.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The approval grants marketing authorisation for first-line use of Trisenox in the 28 countries of the European Union.

Treating low-to-intermediate-risk APL with a chemo-free regimen of Trisenox plus retinoic acid is expected to increase survival rates and reduce the risk of relapse.

University of Rome Tor Vergata, Italy Laboratory of Integrated Diagnosis of Oncohematologic Diseases, Department of Biomedicine and Prevention head Francesco Lo-Coco said: “This approval by the European Commission is good news for APL patients as we now have access to a cure for an acute leukaemia without using chemotherapy.

“From now on, APL patients with non-high-risk disease will have access to this chemotherapy-free regimen of Trisenox plus retinoic acid at diagnosis, which has the potential to increase survival rates while minimising side effects associated with chemotherapy.”

APL is a form of acute myeloid leukaemia (AML), a cancer of the blood-forming tissue.