The European Medicines Agency (EMA) has suggested broaden the authorized use of Gazyvaro (obinutuzumab) to treat patients with follicular lymphoma. The medicine is to be used in amalgamation with bendamustine in patients who were treated before with chemotherapy.
Gazyvaro was first certified in the European Union (EU) in July 2014 for use in combination with chlorambucil in patients having chronic lymphocytic leukaemi and previously untreated.
Follicular lymphoma and chronic lymphocytic leukaemia are both rare types of cancer that affect certain white blood cells that fight infection, called B-lymphocytes. In follicular lymphoma, the body generates abnormal B cells that build up in lymph nodes.
Though useful treatments exist for follicular lymphoma, the disease often comes back and becomes ever more insistent and resistant to existing treatment options. Patients whose disease has become aggressive often die after one to two years.
The active substance in Gazyvaro is a monoclonal antibody that targets B-lymphocytes and triggers the death of cancer cells through the activation of the immune system.
The recommendation from EMA’s Committee for Medicinal Products for Human Use(CHMP) is based on the results of a phase III trial that compared the possessions of Gazyvaro given in permutation with bendamustine and followed by Gazyvaro as a preservation treatment, with the effects of bendamustine alone, in 321 patients with follicular lymphoma who did not respond to or whose disease grow with chemotherapy.
According to the study, patients treated with Gazyvaro in combination with bendamustine lived longer without their disease progressing as compare to patients treated with bendamustine alone.
The general side effects reported with the combination of Gazyvaro and bendamustine were constant with the known safety profiles of the individual medicines.
Because follicular lymphoma is rare, Gazyvaro was nominated as an orphan medicine in 2015. Orphan-designated medicines meet the criteria for ten years’ market exceptionalit.
The outlook adopted by the CHMP at its April 2016 meeting is an intermediary step on Gazyvaro’s path to patient contact. The CHMP opinion will now be sent to the European Commission for the acceptance of a decision on EU-wide marketing authorizations. Once the expansion of suggestion has been granted, a decision about price and compensation will take place at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country.
Date: 29/04/2016