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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



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