Swedish Orphan Biovitrum Submits New Data To CHMP For Kepivance

The new label with an updated SmPC will be implemented after the European Commission has approved the CHMP recommendation.

The pivotal trial published in 2005 where a combination of irradiation and chemotherapy was used, demonstrated Kepivance to be efficacious in oral mucositis. The now initiated variation is based on the results from of a recently completed clinical trial, which at the time of the Marketing Authorisation, was requested by European Medicines Agency (EMA).

The study looked at the effect of Kepivance when one type of chemotherapy-only was used before conditioning preceding hematopoietic stem cell transplantation. In the present study, where multiple myeloma patients received high-dose melphalan (chemotherapy), treatment with Kepivance did not demonstrate a difference in the maximum severity of oral mucositis compared to placebo.

The new European therapeutic indication proposed by the CHMP to the EU Commission reads: Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in patients with hematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous hematopoietic stem cell support.

Kennet Rooth, executive vice president of Swedish Orphan Biovitrum, said: “Kepivance is the only drug approved for the prevention of oral mucositis in Europe and the new label now will be closely aligned with the recommendations by leading professional associations such as the European Society for Medical Oncology (ESMO) to use Kepivance to prevent oral mucositis only in patients with hematological malignancies receiving radiochemotherapy preceding autologous hematopoietic stem cell transplantation.”