Bayer Schering Pharma’s radioimmunotherapy agent Zevalin® ([90Y]-ibritumomab tiuxetan) has moved a step closer to gaining European approval for an additional indication after regulators gave an amber light for the drug as a treatment for the cancer follicular lymphoma.
Bayer Schering Pharma gained a positive opinion from the EU Committee for Medicinal Products for Human Use (CHMP) recommending [90Y]-ibritumomab tiuxetan as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma (FL) in Europe.
The recommendation is based on data from the First-line Indolent Trial (FIT) study.
The study showed an almost two-year improvement in progression-free survival (PFS) in patients with advanced follicular lymphoma receiving [90Y]-ibritumomab tiuxetan vs induction chemotherapy alone.
The multinational, randomised phase III FIT trial involved 414 patients, and investigated [90Y]-ibritumomab tiuxetan as first-line consolidation therapy given as a single therapeutic dose in patients with advanced (stage III or IV) follicular lymphoma who achieved at least a partial remission (PR) or unconfirmed complete response (CRu) or complete remission (CR) after receiving induction chemotherapy regimens.
Data were presented at the American Society of Hematology Annual Meeting in December 2007.
Bayer oncology business unit chief Philip Ashman said [90Y]-ibritumomab tiuxetan was the only approved radiolabelled immunotherapy for adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell non-Hodgkin’s lymphoma (NHL) in Europe.
He said the drug combined the tumour-targeting ability of an anti-CD20 monoclonal antibody with the tumour-destroying power of localised yttrium-90 radiation.
“This recommendation has the potential to provide clinicians with a treatment option that could help many of their patients with follicular lymphoma to extend life without disease progression,” he said.
“The CHMP’s recommendation recognises the value of first-line consolidation therapy with Zevalin as a treatment regimen and the benefit it can offer to patients.”
The recommendation will now be reviewed by the European Commission, which will decide whether to grant marketing authorisation for all EU member states for the drug for this indication.