Tuesday, September 11, 2012


There's some good news for lymphoma patients in Europe - and, potentially, the United States. 

Cell Therapeutics (CTI), the Seattle-based pharmaceutical company, today announced the commercial launch of its aggressive non-Hodgkin's lymphoma drug, Pixuvri, in Europe. 

Pixuvri was granted conditional marketing authorization by the European Commission in May 2012 and is the first drug licensed in Europe to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

According to the European Cancer Observatory, Cancer Fact Sheets, there are approximately 37,000 new cases of aggressive B-cell NHL in Europe every year.

For American lymphoma patients, there is a Pixuvri clinical trial currently open for third-, fourth- and fifth-line patients with diffuse large B-cell lymphoma (DLBCL) who’ve relapsed after therapy with CHOP-R (chemotherapy and Rituxan) or an equivalent regimen and are ineligible for stem cell transplant.

You can learn more about that trial at this link.

Patients with late-stage aggressive NHL who are not eligible for or who've not responded to second-line therapy have very limited treatment options, with average survival of less than a year, according to Dr. Ruth Pettengell, Consultant Hemato-Oncologist at St George's Hospital, London and principal investigator of the Phase III EXTEND study. 

In a statement released today, Pettengell said, "The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines. By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."

According to a May 30th piece in the Lancet, one of the world's leading general medical journal and specialty journals in oncology, neurology and infectious diseases, in the Pixuvri EXTEND study, when compared with other active single-agent  treatments, more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived longer before their disease progressed.

Prior to the approval of Pixuvri there was no standard of care for treating patients who failed front-line and second-line therapy for aggressive B-cell NHL. The EXTEND trial is the only randomized controlled clinical study in this patient population.

"We are pleased to be able to offer the first meaningful treatment option for physicians treating those patients with multiply relapsed and refractory aggressive NHL," James A. Bianco, M.D., President and CEO of CTI, said today in a statement. "CTI looks forward to making this innovative product available to healthcare providers across the European Union."

Could the United States soon follow? We'll be watching this closely.

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