Bayer and partner Genzyme Corp have been boosted by the news that European regulators have recommended marketing authorisation for their oncology agent MabCampath, sold in the USA as Campath, to be used as a first-line treatment for B-cell chronic lymphocytic leukaemia.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on MabCampath (alemtuzumab) for patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate. The drug is already approved for the treatment of B-CLL in patients who have been previously treated with alkylating agents and have failed fludarabine therapy.
The CHMP’s positive opinion is based on data from an international open-label Phase III clinical trial comparing MabCampath with chlorambucil in previously untreated patients with B-CLL, which demonstrated that the Bayer/Genzyme drug showed superior progression-free survival and reduced the risk of disease progression or death by 42%. Patients receiving MabCampath exhibited higher overall and complete response rates with a manageable safety profile, compared to those treated with chlorambucil, and they also achieved extended treatment-free intervals, with a median period of two years before requiring additional therapy.
Gunnar Riemann, a board member at Bayer Schering Pharma, said that the recommendation “underscores the potential of MabCampath to become a standard of care for patients with B-CLL and that therapy with the drug “earlier in the course of treatment represents a significant advance”.
Recommendations by the CHMP are normally endorsed by the European Commission within a couple of months and Bayer said it expects to receive marketing authorisation for all EU member states for this indication later this year. Last month the US Food and Drug Administration gave the firms the go-ahead to market Campath as a first-line treatment for B-CLL.