PhD | Director Therapeutic Innovation and BaseLaunch
Tel. +41 61 295 50 17stephan. emmerth@baselarea. swiss
The Oncologic Drugs Advisory Committee has unanimously recommended Novartis’ CTL019 therapy for approval with the US Food and Drug Administration. It could see the first approved CAR-T therapy become reality in the USA.
The recommendation from the Oncologic Drugs Advisory Committee (ODAC) concerns the treatment of acute lymphoblastic leukemia (ALL) in children and young people, explained Novartis in a statement. It added that ALL is the most common childhood cancer in the USA.
“We're very proud to be expanding new frontiers in cancer treatment,” commented Bruno Strigini, CEO of Novartis Oncology, in the statement. "The panel's unanimous recommendation in favor of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need."
Personalised CAR-T therapy uses the patient’s own cells. The T-cells drawn from the immune system are reprogrammed before being reintroduced into the patient. The cells are then able to recognise and fight certain cancer cells.
The US Food and Drug Administration (FDA) will consider the ODAC’s recommendation when making its final decision on approval. The FDA previously designated CLT019 as a Breakthrough Therapy and granted it Priority Review.
Novartis is planning to file further approval applications in the EU and the USA for different therapies.