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Novartis (NVS) Wins FDA Nod for Label Expansion of Kymriah

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Novartis NVS announced that the FDA has approved a label expansion of its CAR-T cell therapy Kymriah (tisagenlecleucel).

The regulatory body granted accelerated approval to Kymriah for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

The approval is based on data from the phase II ELARA study, a single-arm, open-label program, wherein 90 patients were evaluated for efficacy with a median follow-up of approximately 17 months. 86% of patients treated with Kymriah achieved a response, including 68% who experienced a complete response.

With this recent approval, Kymriah is now approved in the United States for three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. It is approved for the treatment of pediatric and young adult patients (age 3-25 years) with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

It is also approved for 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) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from FL.

In early May 2022, the European Commission approved Kymriah for the treatment of adult patients with r/r FL after two or more lines of systemic therapy.

Sales from Kymriah came in at $587 million in 2021, up 22% from the 2020 figure.

Shares of Novartis have gained 4.6% so far this year compared with the industry’s growth of 6.5%.

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Novartis’ performance in the first quarter was good as the lagging Sandoz business returned to growth and cardiovascular drug Entresto maintained its stellar performance.  Drugs like Cosentyx, Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio should continue to fuel growth and offset the impact of generic competition.

Gilead Sciences’ GILD CAR T-cell Therapy Yescarta was recently approved by the FDA for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

GILD’s Yescarta was initially approved by the FDA in 2017 for a smaller population of LBCL patients who failed two or more lines of therapy.

Novartis currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks are Alkermes ALKS and Geron Corporation GERN. While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

ALKS’ loss estimates for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed on earnings in all the trailing four quarters, the average being 350.48%.

GERN’s loss estimates for 2022 have narrowed 6 cents in the past 60 days. Geron surpassed on earnings in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.



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