Please login to the form below

Not currently logged in

Novartis files CAR-T therapy CTL109 in Europe

Analysts predict Kymriah could become a $1bn-plus product in Europe


Fresh from the first regulatory approval for its CAR-T therapy CTL019 in the US, Novartis has now turned its attention to Europe.

The company has filed a single, catch-up marketing application to the EMA covering the approved use of CTL109 (tisagenlecleucel) - relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL) - as well as follow-up indication diffuse large B-cell lymphoma (DLBCL) which it submitted to the FDA last month.

The EU filing gives Novartis an opportunity to consolidate its position in CAR-T category, a new form of cancer immunotherapy that uses a patient’s own T cell to fight cancer, and keeps CTL109 (sold as Kymriah in the US) on course to achieve what some analysts predict could become $1bn-plus in peak sales.

As in the US, Novartis is filing for approval in children and young adults with relapsed/refractory ALL and in adults with relapsed/refractory DLBCL who are ineligible for a stem cell transplant, based on the results of the ELIANA and JULIET clinical trials.

Novartis is ploughing a new furrow in cancer immunotherapy along with other companies, and in particular Kite Pharma (now part of Gilead Sciences) which has just claimed US approval for its CAR-T Yescarta (axicabtagene ciloleucel) in relapsed/refractory B cell lymphoma.

Kite was the first to file its new therapy in Europe, seeking approval in August for DLBCL, transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) in adults ineligible for a stem cell transplant.

“Since the historic FDA approval of Kymriah…we have launched, manufactured and supplied this highly individualised immunocellular therapy in a commercial setting and the submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world," said CEO-elect Vas Narasimhan, who is currently Novartis’ chief medical officer.

The company said it is planning additional regulatory submissions for CTL019 in paediatric and young adult patients with B-cell ALL and adults with DLBCL outside the US and EU in 2018.

Article by
Phil Taylor

6th November 2017

From: Sales



Featured jobs

Subscribe to our email news alerts


Add my company
Wilmington Healthcare

A heritage to envy Wilmington Healthcare brings together the data intelligence specialisms of Binley’s, NHiS, Wellards and HSJ to create...

Latest intelligence

The Biosimilar Challenge
How health behaviours and clinical outcomes are related
When HCPs understand patient activation levels they can actively guide patients towards more confident self-management of diverse health concerns....
The Periodic Table of Healthcare Communications
The definitive framework for building healthcare communication strategies and plans. Covering Brand Planning, Customer Experience and Multi-channel Marketing....