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Novartis' CAR-T Therapy Kymriah Gets Approval in Europe

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Novartis AGNVS announced that the European Commission (EC) has approved chimeric antigen receptor T cell (CAR-T) therapy, Kymriah (tisagenlecleucel).

Kymriah is approved for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in Europe.

Kymriah was designated as an orphan medicinal product and is one of the first PRIME-designated therapies to receive EC approval.

We note that Kymriah, a one-time treatment that uses a patient's own T cells to fight cancer, was developed in collaboration with University of Pennsylvania (Penn).

The approval was based on positive data from two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from eight European countries. Kymriah demonstrated strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations.

Novartis already signed an agreement for manufacturing CAR-T therapies with CELLforCURE, one of the first and largest Contract Development and Manufacturing Organization in Europe producing cell and gene therapies.

Kymriah is already approved in the United States. The FDA recently expanded Kymriah's label for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

The uptake has been encouraging so far. Kymriah sales came in at $28 million in the first half of 2018.

Novartis is looking to solidify its presence in the gene-therapy space. It recently acquired U.S.-based clinical stage gene-therapy company, AveXis, Inc. Earlier in 2018, Novartis announced a licensing agreement with Spark Therapeutics ONCE covering development, registration and commercialization rights to voretigene neparvovec outside the United States.

However, competition is expected to stiffen from the likes of Gilead's GILD Yescarta.

Approval of new drugs and label expansion of key drugs bode well for Novartis.

Novartis' shares have declined 3.4% in the year so far compared with the industry 's gain of 8.2%.

The company restructured its business and plans to focus on becoming a core drug-focused company, powered by data and digital technologies. It is looking to spin-off its ophthalmology division, Alcon. Earlier, Novartis also divested its stake in the OTC joint venture with GlaxoSmithKline GSK for $13 billion.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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