Image

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences‘ marketing authorisation application for Zydelig to treat chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).

Zydelig has been recommended for use in combination with rituximab to treat adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

It is also recommended as monotherapy for treatment of adult patients with FL that is refractory to two prior lines of treatment.

"In the Phase II 101-09 study, Zydelig’s safety and efficacy has been evaluated in patients with indolent non-Hodgkin’s lymphoma who are refractory to rituximab and alkylating agents."

The European Commission will now review the CHMP’s recommendation for Zydelig. Its recommendation for approval in the EU is supported by positive data from the Phase III (Study 116) trial and the Phase II (Study 101-09) trial.

The Phase III Study 116 has evaluated the safety and efficacy of Zydelig in combination with rituximab in patients with previously treated CLL.

See Also:

In the Phase II 101-09 study, Zydelig’s safety and efficacy has been evaluated in patients with indolent non-Hodgkin’s lymphoma who are refractory to rituximab and alkylating agents.

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.

Diarrhoea, pyrexia, fatigue, nausea, cough, abdominal pain and chills were the most commonly reported adverse reactions in these studies.

Gilead Sciences recently received approval from the US Food and Drug Administration (FDA) for Zydelig (idelalisib) 150mg tablets for the treatment of CLL, FL, and small lymphocytic lymphoma. Zydelig is an oral inhibitor of phosphoinositide 3-kinase delta.

Image: Zydelig is recommended for approval in EU to treat chronic lymphocytic leukaemia and follicular lymphoma. Photo: courtesy of BusinessWire/Gilead Sciences, Inc.