The European Medicines Agency (EMA) has recommended the extension of the authorised indication of Roche’s Gazyvaro (obinutuzumab) to treat patients affected with follicular lymphoma.
Gazyvaro must be used in combination with bendamustine on patients who were earlier treated with chemotherapy.
In July 2014, the medicine was first authorised in the European Union (EU) for use in combination with chlorambucil in patients suffering from previously untreated chronic lymphocytic leukaemia.
Both follicular lymphoma and chronic lymphocytic leukaemia are rare types of cancer that affect specific white blood cells used to fight infection, known as B-lymphocytes.
In case of follicular lymphoma, the body of the patient produces abnormal B cells that build up in lymph nodes.
Though follicular lymphoma has effective treatment options, the disease often reverts only to make it more aggressive and resistant to existing treatment options.
Gazyvaro comprises monoclonal antibody that targets B-lymphocytes and activates the immune system, thereby destroying the cancer cells in the body.
EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug based on the results of a Phase III trial on follicular lymphoma patients, who either did not respond to or whose disease increased with chemotherapy.
The trial revealed that patients treated with Gazyvaro, conbined with bendamustine, lived longer than the ones treated with bendamustine alone.
Last month, CHMP adopted the opinion as an intermediary step to make Gazyvaro accessible to patients.
The opinion will be sent to the EC to decide on EU-wide marketing authorisations of Gazyvaro.
Image: Follicular lymphoma replaces a lymph node. Photo: courtesy of Emmanuelm.