Novartis’s new cancer therapy accepted for European regulatory review

Novartis has announced that its newest cancer therapy has been accepted for regulatory review by the European Medicines Agency.

The regulator has ratified the company's marketing authorisation application for CTL019 as a treatment for children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia, and for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplant.

This novel immunocellular therapy is a one-time treatment that uses a patient's own T cells to fight cancer, and has shown promise in the phase II ELIANA and JULIET trials, data from which was used to support this application.

It is hoped that the treatment will address an unmet need for new therapies among patients with these forms of cancer, who currently have few options and historically poor outcomes.

Vas Narasimhan, global head of drug development and chief medical officer at Novartis, said: "We look forward to working with the European Medicines Agency to make CTL019 available to the children and adults who may benefit from this novel therapy."

The firm is also seeking US regulatory approval of the drug in a diffuse large B-cell lymphoma indication.

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