Bayer receives positive CHMP opinion for MabCampath

Bayer Schering Pharma and Genzyme Corporation have announced that MabCampath has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP).

The European body recommended that MabCampath (alemtuzumab) was granted marketing authorisation for the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) where fludarabine combination chemotherapy was not appropriate.

Bayer and Genzyme will now expect to see MabCampath receive marketing authorisation in all EU member states by the end of the year, provided the European commission acts on the CHMP’s recommendations.

Gunnar Riemann, member of the board of management at Bayer, expressed the importance of the committee’s recommendation in highlighting the potential of MabCampath for patients with B-CLL.

“We commend the committee’s thorough review of the MabCampath clinical data and believe that therapy with MabCampath earlier in the course of treatment represents a significant advance for B-CLL patients.”

The CHMP positive opinion follows an international open-label Phase III clinical trial where MabCampath was compared to chlorambucil in previously untreated patients with B-CLL.

Last month, Bayer HealthCare and Onyx Pharmaceuticals announced that Nexavar (sorafenib) had received a positive opinion from the CHMP, with the committee recommending the approval of the compound as a treatment for hepatocellular carcinoma