Basic Information
Gazyvaro
Regulatory Information
EMEA/H/C/002799
July 22, 2014
May 21, 2014
17
October 23, 2024
Company Information
Germany
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
Roche Registration GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Chronic Lymphocytic Leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1). Follicular Lymphoma (FL) Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma. Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Overview Summary
Gazyvaro is a cancer medicine used to treat adults with: - previously untreated chronic lymphocytic leukaemia (CLL). CLL is a cancer of B-lymphocytes, a type of white blood cell. Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended; - follicular lymphoma (FL), another type of cancer of B-lymphocytes. Gazyvaro is used together with chemotherapy (other cancer medicines) in patients who have not had previous treatment for advanced FL. It is also used with the medicine bendamustine in patients whose disease has not responded to treatment involving the medicine rituximab or whose cancer has progressed within 6 months after such treatment. Once the disease has responded to treatment, Gazyvaro is then used on its own for the maintenance treatment of FL. Gazyvaro contains the active substance obinutuzumab. These diseases are rare, and Gazyvaro was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (CLL: [10 October 2012](/en/medicines/human/orphan-designations/eu-3-12-1054); FL: [19 June 2015](/en/medicines/human/orphan-designations/eu-3-15-1504)).