Pixuvri EMA approval : French pharma company Servier has secured full approval for Pixuvri (pixantrone) from the European Commission (EC) as monotherapy for aggressive non-Hodgkin B-cell lymphoma (NHL) in adult patients whose condition is multiply relapsed or refractory.
Pixuvri EMA approval
Since 2012, Pixantrone has been available in Europe to patients following conditional approval, which has now been converted into a standard marketing authorization based on the data from the drug’s global clinical development.
In the phase 3 trial called PIX301, Pixuvri monotherapy was pitted against physician’s choice of treatment in 140 patients having relapsed or refractory aggressive non-Hodgkin lymphoma, of which 50% of the participants were subjected to treatment with rituximab. Pixuvri proved to be beneficial in this lot of patients, with 20% of them showing full response to the cytotoxic drug in comparison to 5.7% of patients who received other agents.
The trial was to meet the requirements of the conditional authorization and was executed to register additional efficacy data to confirm the benefit of Pixuvri in patients who were previously treated with regimens containing rituximab.
An additional phase 3 clinical trial, called PIX306, to meet requirements of the conditional authorization, was undertaken to gather additional efficacy data to confirm Pixuvri’s benefit in patients who were previously treated with rituximab-containing regimens.
In this late-stage trial, the superiority of Pixuvri with rituximab in comparison with gemcitabine with rituximab was not met. However, progression-free survival and overall survival results in patients with at least prior treatment lines were identical, when compared indirectly to the Pixuvri treated population in the PIX301 clinical trial.
Commenting on Pixuvri EMA approval, Patrick Therasse – Head of Servier Research and Development Oncology, said: “At Servier, we work diligently to develop and deliver medicines that address critical unmet medical needs in diseases such as multiply relapsed or refractory aggressive non-Hodgkin lymphoma.
“Pixuvri has been benefitting patients since its conditional approval in 2012 but today’s decision brings reassurance to patients and clinicians that this medicine remains a relevant treatment option in this indication.”
The most common Pixuvri side effects are neutropenia, leukopenia, lymphopenia, anemia, thrombocytopenia, alopecia, nausea, skin discoloration, vomiting, chromaturia, and asthenia.
Prof Pier Luigi Zinzani from the Italy-based University of Bologna Institute of Hematology and Medical Oncology, commenting on Pixuvri EMA approval, said: “There are limited treatment options for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma,” said
“Pixuvri has demonstrated efficacy in late stage disease and the EC approval confirms Pixuvri as a treatment option for these patients.”