Data from Pharmawand - Curated by EPG Health - Date added 10 July 2018

CTI BioPharma Corp. and Servier announced that the pivotal Phase III trial (PIX306) evaluating Pixuvri (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of an improvement in progression-free survival (PFS).

Results from the study will be submitted to a peer-reviewed journal for publication. The PIX306 trial is a randomized, multicenter trial comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL)

Pixuvri has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data. The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Breakthrough Cancer Pain Learning Zone

Breakthrough Cancer Pain Learning Zone

Watch video highlights from the BeCOn OWN 2017 event, including expert opinion, patient experience and panel discussions in the Breakthrough Cancer Pain Learning Zone.

Biosimilars in Oncology Knowledge Centre

Biosimilars in Oncology Knowledge Centre

What are biologics and how do they differ from small molecule medicines? Discover more about their development, as well as the manufacturing and regulatory processes in the Biosimilars in Oncology Knowledge Centre.

Load more

Related Content