MADRID 9 May. (EUROPA PRESS) –
The European Commission (CE) has approved the use of ‘Calquence’ (Acalabrutinib), developed by Astrazeneca, in combination with cheminemunotherapy based on Bendamustina and Rituximab, for the treatment of adult patients with mantle cell lymphoma (LCM) not previously treated and not eligible for autologous stem cell transplant.
This was announced this Friday the Biopharmaceutical Company, which has indicated that this approval follows the positive opinion issued by the Human Use Medicines Committee (CHMP) of the European Medication Agency (EMA) on this therapy indicated for LCM, a rare and typically aggressive form of non -Hodgkin lymphoma, which is usually diagnosed in An advanced stage.
The resolution, which will allow its use throughout the European Union (EU), is based on the positive results of the phase III ‘echo’ test, which testified the combination with ‘Calquence’ in a sample of 635 patients and showed that it reduced the risk of disease progression or death by 27 percent compared to the standard of chemoimmunotherapy treatment.
-In addition, this study showed a median progression -free survival (SLP) of 66.4 months for patients treated with the combination, compared to 49.6 months of those who were treated with chemoimmunotherapy alone, which implies a 16 -month difference. The safety and tolerability of the drug were consistent with their known security profile, and new safety signs were identified.
“This approval provides a new first -line treatment option for EU patients with mantle cell lymphoma, an aggressive lymphoma with discouraging long -term results even today,” said the doctor of the Department of Medicine at the LMU University Hospital of Munich (Germany) and researcher at the Martin Dreyling test.
The combination is approved in the United States, as well as in other countries in this context, based on the results of ‘Echo’. At present, the respective regulatory agencies are studying authorization requests in Japan and other countries for this indication.
This approval follows the recent approval of the drug in the EU in monotherapy for the treatment of adult patients with LCM in relapse or refractory.
 more chemoimmunotherapy for mantle cell lymphoma){kind=link}