Bayer says that it has won an extended approval from the European Commission for its radioimmunotherapy treatment Zevalin.

The green light means that Zevalin ([90Y]-ibritumomab tiuxetan) can be used in the course of a first-line therapy after remission induction in previously untreated patients with follicular lymphoma. The drug has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin’s lymphoma since 2004.

The approval is based on data from a Phase III trial which showed that, when used as first-line consolidation therapy - which is given after a patient responds to a first-line induction therapy, ie chemotherapy, Zevalin significantly prolonged progression-free survival time from 13.5 months to 37 months.

Anton Hagenbeek of the Academic Medical Centre, Amsterdam, and lead investigator of the aforementioned trial, said “it is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression-free survival by two years, with a favourable toxicity profile”. He added that the results show radioimmunotherapy “is a very effective single agent in the treatment of follicular lymphoma”, which is one of the most common types of indolent NHL.

Encouraging AMD data for VEGF Trap-Eye
Bayer has also presented encouraging 32-week follow-up results from a Phase II study of its vascular endothelial growth factor blocker, VEGF Trap-Eye, in age-related macular degeneration, the leading cause of blindness for people over 65 in the USA and Europe.

The data, which was presented at Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale, demonstrated that patients on VEGF Trap-Eye – which is being developed with Regeneron Pharmaceuticals – achieved a 6.6 mean letter gain in visual acuity versus baseline at week 16 following 12 weeks of fixed dosing, which was maintained to week 32. The decrease in retinal thickness was also maintained for all dose groups at 32 weeks.

Bayer and Regeneron are hoping that VEGF Trap-Eye will become a strong competitor to Genentech’s Lucentis (ranibizumab) and the two companies are carrying out two Phase III trials comparing the two compounds.