Rebecca Araujo

DocwireNews

On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (axi-cel) for the treatment of relapsed/refractory follicular lymphoma (FL) following two or more lines of therapy.Axi-cel, developed by Gilead subsidiary Kite Pharma and sold commercially as Yescarta, is a chimeric antigen receptor (CAR) T-cell therapy previously approved for the treatment of relapsed/refractory large B-cell lymphoma. It is the first CAR T-cell therapy approved for FL.&ldquo;As we look to bring the hope of survival to more patients in need, today&rsquo;s FDA decision represents a real step forward in our commitment in hematologic malignancies,&rdquo; said Christi Shaw, Chief Executive Officer of Kite, in a <a href="https://www.gilead.com/news-and-press/press-room/press-releases/2021/3/us-fda-approves-yescarta-for-relapsed-or-refractory-follicular-lymphoma-after-two-or-more-lines-of-systemic-therapy">press release</a>. &ldquo;Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development program, and we are excited about the potential of Yescarta for patients with indolent FL.&rdquo;The approval is supported by data from the multicenter ZUMA-5 study, which evaluated the efficacy and safety of axi-cel in 81 patients with FL. Overall, 91% of patients responded to a single infusion of axi-cel, with 60% achieving a complete response. Median duration of response has yet to be reached in the study cohort.The most common grade 3 or higher adverse events, occurring in more than 10% of patients, includes febrile neutropenia, encephalopathy, and infection. The treatment comes with a boxed warning for risks of cytokine release syndrome and neurologic toxicities.<blockquote class="twitter-tweet">
:: FDA Update:: <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> approves axicabtagene ciloeucel (YESCARTA, Kite, a Gilead Company) for adult patients with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. Read more about this approval: <a href="https://t.co/lOVwTxx2Ie">https://t.co/lOVwTxx2Ie</a>
&mdash; Lymphoma Research Foundation (@lymphoma) <a href="https://twitter.com/lymphoma/status/1368998777437163525?ref_src=twsrc%5Etfw">March 8, 2021</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><blockquote class="twitter-tweet">
<a href="https://twitter.com/hashtag/NEWS?src=hash&amp;ref_src=twsrc%5Etfw">#NEWS</a>: We are pleased to announce the <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> has granted accelerated approval to our <a href="https://twitter.com/hashtag/CARTcell?src=hash&amp;ref_src=twsrc%5Etfw">#CARTcell</a> therapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
&mdash; Kite, a Gilead Company (@KitePharma) <a href="https://twitter.com/KitePharma/status/1368002374783049730?ref_src=twsrc%5Etfw">March 6, 2021</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>

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FDA Approves First CAR T Therapy for Follicular Lymphoma

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On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (axi-cel) for the treatment of relapsed/refractory follicular ...

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