One approval is for Actemra/RoActemra, which is the first therapy approved for the treatment of giant cell arteritis (GCA) in Europe, according to a Roche statement. The autoimmune condition causes blood vessels in the head, neck, and aorta to become inflamed and thickened, which reduces blood flow and can result in irreversible blindness.
“We are delighted that Actemra/RoActemra has been approved for the treatment of GCA in Europe,” said Sandra Horning, Chief Medical Officer at Roche. “As the first effective non-steroid therapy for GCA, Actemra/RoActemra has the potential to fundamentally change how this condition is treated.”
The European Commission also approved Gazyvaro, which is used in combination with chemotherapy to treat people with previously untreated advanced follicular lymphoma. Each year some 19,000 people in Europe are diagnosed with the disease. With the approval of Gazyvaro, “these patients now have an improved initial treatment option available to them,” explained Horning.
Gazyvaro has already been approved in the EU for people with previously untreated chronic lymphocytic leukaemia and for people with follicular lymphoma who did not respond during other treatments.
The third approval is for TECENTRIQ (atezolizumab), a monotherapy for the treatment of a specific type of metastatic lung cancer and two types of metastatic bladder cancer. Accordingto Horning, it is the first anti-PD-L1 cancer immunotherapy approved in the EU as a monotherapy in both advanced bladder and advanced lung cancer.
TECENTRIQ is already approved in the U.S. and in several other countries for people with metastatic non-small cell lung cancer.