Drug Development, FDA

Kymriah wins second FDA OK, boosting hope for Novartis’ low CAR-T sales

After disappointing investors this year with sluggish sales, the prospects for Novartis’ CAR-T therapy Kymriah may be improving. The FDA has handed the pharma giant its second approval for the drug, the company said Tuesday afternoon.

The drug, which was first approved last August for patients under 25 with B-cell precursor acute lymphoblastic leukemia, is now OK’ed to treat large B-cell lymphoma. The cancer must be relapsed or refractory, and the patient must have gone through two or more lines of systemic therapy first.

Kymriah — the first CAR-T ever to get approval — is now also the first CAR-T to get approval for two distinct indications in non-Hodgkin lymphoma (NHL) and B-cell ALL.

Liz Barrett

“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 of Novartis Oncology, in a statement. “We look forward to leveraging all of our learnings and new capabilities from the initial launch of Kymriah in pediatric and young adult B-cell ALL for this larger group of patients.”

Kymriah was a bit of a disappointment to $NVS investors when Q1 results came out. In the first quarter of 2018, the treatment brought in $12 million, which is roughly four times below the sales needed to meet analyst expectations of around $159 million for the year.

The cost of Kymriah ($475,000) could be part of the problem, but there’s also the small patient group to consider. Its first indication is a rare cancer that affects only 3,100 new patients each year, and the drug only targets roughly 30% of those patients who do not respond to standard therapy.

The new approval will add to that patient pool and give investors reason to hope for better sales figures down the road.


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