Bayer Schering Pharma’s radioimmunotherapy agent Zevalin moved a step closer to winning European approval for an additional indication yesterday after regulators issued an amber light for the drug as a treatment for the cancer follicular lymphoma.

Specifically, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that Zevalin ([90Y]-ibritumomab tiuxetan) be cleared as a consolidation therapy in previously untreated patients, adding to its already approved indication of follicular B-cell non-Hodgkin's lymphoma.

According to the company, the drug works by combining the tumour-targeting capabilities of an anti-CD20 monoclonal antibody with the tumour-destroying power of localised radiation, with the radiolabeled antibodies latching on to the tumour to kill targeted and neighbouring lymphoma cells.

Extending progression-free survival
The CHMP thumbs up is based on data from a pivotal Phase III trial which showed that, when used as first-line consolidation therapy - which is given following an adequate response to a first-line induction therapy to boost the quality and duration of a patient’s response - Zevalin was able to significantly prolong progression-free survival from 13.5 months to 37 months, and thereby represents a promising new option for helping to keep the disease at bay for longer.

“The CHMP’s recommendation represents an important milestone for Zevalin, as it recognises the potential value that consolidation therapy with Zevalin can offer to patients with follicular lymphoma,” remarked Dr Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. And explaining the drug’s potential, he added: “This therapy option will provide clinicians with a treatment regimen that truly could help many of their patients to an extended progression-free survival”.