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Novartis aims for CAR-T double-approval in Europe

Published on 06/11/17 at 09:07am

Just last week Novartis revealed it had applied to the FDA for a new indication in diffuse large B-cell lymphoma (DLBCL) for its CAR-T treatment, Kymriah, now the company has gone to the EMA hoping to secure two indications at the same time – jump starting its presence in the European market.

The other indication it is applying for is in acute lymphoblastic leukaemia (ALL), the type of blood cancer that Kymriah has already received approval for by the FDA.

The MAA application for DLBCL sees Novartis move directly into the same territory that CAR-T rival Gilead has already gained approval for in the US.

Yescarta was approved by the FDA in mid-October and Kite Pharma, previously acquired by Gilead, had already applied to the EMA in July for marketing authorisation for DLBCL.

The main differentiator between the two therapies, that exhibit similar outcomes in therapeutic results, is the pricing strategies.

In US, Novartis’ treatment costs $474,000 per treatment but has offered to reimburse treatment costs in patients who do not exhibit a response in one month. Gilead will only offer a flat rate of $373,000 per patient.

How these different approaches to pricing will differ should both treatments receive marketing approval in Europe remains to be seen. Novartis has not yet indicated what its approach will be and it could one of the more interesting signposts of its pricing strategy.

“Since the historic FDA approval of Kymriah, formerly CTL019, we have launched, manufactured and supplied this highly individualized immunocelluar 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 Vas Narasimhan, Global Head of Drug Development, CMO and soon-to-be CEO of Novartis. “We look forward to working with the EMA to make CTL019 available to the children and adults who may benefit from this novel therapy.”

The news in CAR-T is beginning to come thick and fast, with Juno Therapeutis releasing results of its own therapy that could pitch it as the best in class treatment. It revealed a three month complete response rate of 73% in DLBCL that could turn the competition into a three-way fight, albeit one where Juno, if it can sustain such results, would blow both Novartis and Gilead out of the water.

Ben Hargreaves

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