Novartis becomes first to gain second CAR-T indication

Novartis has announced that its CAR T treatment, Kymriah, has successfully been given a second indication for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of treatment.

The approval brings Kymriah into the same market space occupied by Gilead’s rival treatment, Yescarta. Most importantly for Novartis, It opens up a new patient pool and will see sales of the drug increase, after a sluggish start to life on the market.

Novartis revealed that Kymriah had brought in just $12 million in the first quarter of the year, well below expectations.

It should be said that its first indication, in paediatric leukaemia, only had a small pool of patients and had a pricing structure that meant payment was only required if the treatment was successful within the first 30 days of treatment.

The company is still waiting for approvals in the EU in both indications, with a decision expected in the second half of this year, which could slowly see the treatment accrue a larger patient population and begin to generate more revenue. There are around 10,000 patients that could be eligible to receive the treatment each year.

"Today's FDA approval of Kymriah provides another opportunity for Novartis to build on its leadership in CAR-T development, delivering a potentially transformative therapy with durable and sustained response rates and a well-characterized safety profile to help patients in dire need of new treatment options," said Liz Barrett, CEO, Novartis Oncology. "We look forward to leveraging all of our learnings and new capabilities from the initial launch of Kymriah in paediatric and young adult B-cell ALL for this larger group of patients."

This leadership does not extend to offering a similar pay-for-outcomes structure in this new indication, instead the company has decided to match the price of Yescarta, at $373,000.

With the treatments the only two CAR T treatments currently approved, they can be expected to battle it out beyond this indication – with pricing, as high as it currently is, could be a potential differentiator between the two.

It looks like, by matching Gilead’s price, Novartis is not currently interested in undercutting its rival and thereby beginning to weaken both treatments’ ability to maintain large list price.

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