Novartis files European marketing application for vehicle T tisagenlecleucel

Novartis files European marketing application for vehicle T tisagenlecleucel”

Swiss drugmaker Novartis has submitted its cell therapy Kymriah for European approval in two forms of blood cancer, seeking to expand the use of a new treatment it hopes will eventually become a $1 billion-a-year seller.

Back in August CLT019 (tisagenlecleucel) became the first cell therapy to be approved in the U.S., under the brand name Kymriah, as a treatment for relapsed/refractory ALL, and it has also now been filed in the country for r/r DLBCL.

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.

Separately, Novartis reported new long-term Cosentyx (secukinumab) data for patients with ankylosing spondylitis.

Gilead charges $373,000 for Yescarta per patient. Nearly 80 percent of patients had no radiographic progression for as long as 4 years.

Side effects of the drug can be fearsome and must be carefully managed as the immune system goes into overdrive.

Without giving further details, the company noted it could receive more than $100m from Novartis over the next three years.

Novartis' filing is based on the Novartis-sponsored global, multicentre, phase 2 ELIANA and JULIET trials, which were conducted in collaboration with the University of Pennsylvania, where the therapy was first developed.

Vehicle T-cell therapies have started to gain approvals in recent months. The primary analysis results of the trial will be presented at the American Society of Hematology annual meeting, to be held December 9-12 in Atlanta.

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 United States and European Union in 2018.

Auto T-cell therapy involves tailoring the agent specifically to each patient.

"We've seen durable complete responses in patients who previously relapsed or were refractory to prior therapies, and this second filing is a significant step toward realizing its potential for even more patients who are now battling fatal blood cancers", Schuster said.

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