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</div> <h1 class="post-single__title"> ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer </h1> <div class="post-single__excerpt"> <p>Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. </p> </div> <div class="post-single__meta"> <div class="post-single__byline"> <span class="post-single__byline-author">By <a href="https://medcitynews.com/author/fvinluan/">Frank Vinluan</a> <span> on November 10, 2024</span> </span> </div> <div class="post-social-share"> <button class="post-social-share__trigger"> <div class="post-social-share__icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 512 512"><path d="m503.7 189.8-176-151.9C312.3 24.5 288 35.3 288 56v80.1c-160.6 1.8-288 34-288 186.2 0 61.4 39.6 122.3 83.3 154.1 13.7 9.9 33.1-2.5 28.1-18.6-45.3-145 21.5-183.5 176.6-185.7V360c0 20.7 24.3 31.5 39.7 18.2l176-152c11.1-9.6 11.1-26.8 0-36.3z"/></svg> </div> <span class="post-social-share__label"><strong>Share</strong></span> </button> <div class="post-social-share__container"> <p 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<div class="ad ad--top_leaderboard--mobile ad--format-leaderboard ad--mobile-only" id="ad--top_leaderboard--mobile top_leaderboard--mobile"> <div class="ad__wrapper"> <div id="ad-top_leaderboard--mobile"></div> </div> </div> <div class="content"> <figure class="post-single__featured-image"> <img width="600" height="396" src="https://medcitynews.com/wp-content/uploads/sites/7/2024/02/GettyImages-1637352864-600x396.jpg" class="attachment-large size-large wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://medcitynews.com/wp-content/uploads/sites/7/2024/02/GettyImages-1637352864-600x396.jpg 600w, https://medcitynews.com/wp-content/uploads/sites/7/2024/02/GettyImages-1637352864-300x198.jpg 300w, https://medcitynews.com/wp-content/uploads/sites/7/2024/02/GettyImages-1637352864.jpg 727w" sizes="(max-width: 600px) 100vw, 600px" /> </figure> <div class="post-single__content"> <p>An Autolus Therapeutics cell therapy has won <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute" target="_blank" rel="noopener">FDA approval</a> for treating an aggressive blood cancer. It’s the biotech’s first approved product and just the second CAR T-treatment for adults who have this particular malignancy. But compared to that other cell therapy and other treatments available, Autolus’s therapy has features that could set it apart from the field.</p> <p>The Autolus therapy, known in development as obecabtagene autoleucel, or obe-cel, is approved to treat adults with advanced cases of B-cell precursor acute lymphoblastic leukemia (ALL). The Friday approval came ahead of the Nov. 16 target date for an FDA decision. London-based Autolus will market its new therapy under the name Aucatzyl.</p> <p>In B-cell ALL, the bone marrow produces too many abnormal B-lymphocytes, a type of white blood cell. Aucatzyl is a CAR T-cell therapy made by harvesting a patient’s T cells and engineering them to go after CD19, a protein abundant on the surfaces of those abnormal cells. It’s the same target addressed by Gilead Sciences’ Tecartus, which received <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic" target="_blank" rel="noopener">FDA approval for ALL in 2021</a>. But Aucatzyl is engineered to offer better safety and efficacy.</p> <div><div class="ad ad--inline_top ad--format-square ad--mobile-only" id="ad--inline_top inline_top"> <div class="ad__wrapper"> <div id="ad-inline_top"></div> </div> </div> <div class="post-card__wrapper has-sponsor-banner post-card--is-sponsored has-gray-background"> <div class="presented-by-sponsor-banner presented-by-parlance" style="border-bottom: 5px solid"> <div class="presented-by-text"> presented by </div> <div class="presented-by-sponsor-logo"> <img src="https://medcitynews.com/wp-content/uploads/sites/7/2024/07/Parlance_Logo-1-1024x300.jpg" style="width: 115px;height: auto" loading="lazy"> </div> </div> <article id="post-133380" class="post-card post-card--has-thumbnail " data-title="What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations " data-url="https://medcitynews.com/2025/01/what-keeps-healthcare-cios-up-at-night-balancing-technology-investments-with-consumer-expectations/"> <div class="post-card__categories"> <span class="post-single__category post-single__category--text"> <a href="https://medcitynews.com/category/channel/artificial-intelligence/" rel="category tag"> Artificial Intelligence </a> </span> </div> <figure class="post-card__thumbnail"> <a href="https://medcitynews.com/2025/01/what-keeps-healthcare-cios-up-at-night-balancing-technology-investments-with-consumer-expectations/" class="post-card__thumbnail-link"> <img width="360" height="200" src="https://medcitynews.com/wp-content/uploads/sites/7/2025/01/GettyImages-153405991-360x200.jpg" class="attachment-post-card-sm size-post-card-sm wp-post-image" alt="" decoding="async" srcset="https://medcitynews.com/wp-content/uploads/sites/7/2025/01/GettyImages-153405991-360x200.jpg 360w, https://medcitynews.com/wp-content/uploads/sites/7/2025/01/GettyImages-153405991-576x320.jpg 576w" sizes="(max-width: 360px) 100vw, 360px"> </a> </figure> <div class="post-card__content"> <h3 class="post-card__title"> <a href="https://medcitynews.com/2025/01/what-keeps-healthcare-cios-up-at-night-balancing-technology-investments-with-consumer-expectations/" class="post-single__title-link"> What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations  </a> </h3> <p class="post-card__excerpt content"> When it comes to managing inbound phone calls, underperformance has devastating cost implications. </p> <div class="post-card__byline"> <a href="https://medcitynews.com/2024/11/autolus-car-t-cell-therapy-obe-cel-aucatzyl-fda-approval-b-cell-all-blood-cancer-leukemia/"> By Stephanie Baum </a> </div> </div> </article> </div> <div class="ad ad--youtube1x1 ad--format-1x1" id="ad--youtube1x1 youtube1x1"> <div class="ad__wrapper"> <div id="ad-youtube1x1"></div> </div> </div> </div><p>After recognizing and binding to CD19, Aucatzyl injects its cytotoxic proteins and then disengages from the cancer cell to move on to another cancer cell, a process called “serial killing.” To be fair, other CAR T-therapies, including Tecartus, offer serial killing capability. But Aucatzyl is designed to disengage from each target cell more rapidly than other cell therapies do. This fast “off-rate” is intended to minimize excessive activation of T cells, which in turn could reduce adverse effects to patients. This property could also reduce exhaustion of these engineered cells, thereby improving the therapy’s durability.</p> <p>The FDA’s decision for Aucatzyl is based on the results of an open-label, single-arm trial that enrolled adults with CD19-positive B-cell ALL that had relapsed or had not responded to at least two earlier lines of treatment. The main goal was to measure the rate and duration of complete remission. Of the 65 patients who could be evaluated for efficacy, 27 (42%) achieved complete remission within three months. The median duration of that response was 14.1 months.</p> <p>Aucatzyl’s label carries a black box warning for an excessive immune response called cytokine release syndrome. The warning also flags risks of neurotoxicity and T cell malignancies. <a href="https://medcitynews.com/2024/01/fda-calls-for-new-safety-warning-for-the-class-of-car-t-cancer-therapies/" target="_blank" rel="noopener">Those risks are consistent with the class of CAR T-therapies, which also carry black box warnings</a>. But the rates of severe complications for the Autolus therapy were low. While cytokine release syndrome was reported in 75% of patients, this complication was classified at Grade 3 in just 3% of patients and there were no Grade 4 or 5 events. Neurotoxicity was reported in 64% of participants; this complication was Grade 3 or higher in just 12% of cases.</p> <div class="ad ad--inline_middle ad--format-square ad--mobile-only" id="ad--inline_middle inline_middle"> <div class="ad__wrapper"> <div id="ad-inline_middle"></div> </div> </div><p>In a note sent to investors on Friday, William Blair analyst Matt Phipps said the response rates for Aucatzyl are similar to those of Tecartus. Where Autolus’s drug differentiates itself is with better safety. Phipps notes that Aucatzyl’s rates of complications are lower. He added that unlike other CAR T-therapies, the FDA is not requiring the Autolus product to have a risk evaluation mitigation strategy (REMS), a program that monitors and mitigates the risks of a treatment.</p> <div class="post-card__wrapper post-card--is-sponsored "> <article id="post-133082" class="post-card post-card--has-thumbnail " data-title="Improving the Healthcare Financial Experience to Help Care Flow" data-url="https://medcitynews.com/2025/01/improving-the-healthcare-financial-experience-to-help-care-flow/"> <div class="post-card__categories"> <span class="post-single__category post-single__category--text"> <a href="https://medcitynews.com/category/exclusive/" rel="category tag"> Exclusive </a> </span> </div> <figure class="post-card__thumbnail"> <a href="https://medcitynews.com/2025/01/improving-the-healthcare-financial-experience-to-help-care-flow/" class="post-card__thumbnail-link"> <img width="360" height="200" src="https://medcitynews.com/wp-content/uploads/sites/7/2025/01/Amanda-EiselThumbnail-360x200.jpg" class="attachment-post-card-sm size-post-card-sm wp-post-image" alt="" decoding="async"> </a> </figure> <div class="post-card__content"> <h3 class="post-card__title"> <a href="https://medcitynews.com/2025/01/improving-the-healthcare-financial-experience-to-help-care-flow/" class="post-single__title-link"> Improving the Healthcare Financial Experience to Help Care Flow </a> </h3> <p class="post-card__excerpt content"> Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all. </p> <div class="post-card__byline"> <a href="https://medcitynews.com/2024/11/autolus-car-t-cell-therapy-obe-cel-aucatzyl-fda-approval-b-cell-all-blood-cancer-leukemia/"> By Stephanie Baum </a> </div> </div> </article> </div><p>“We continue to believe the more tolerable safety profile of Aucatzyl will make it the preferred treatment option for patients with adult ALL and support majority market share over time,” Phipps said. “Interestingly, Aucatzyl is the first CAR T-therapy to be approved without a REMS requirement, which should reduce burden for the treating centers and further support adoption.”</p> <p>Aucatzyl’s safety edge could also support expanding the product’s uses to certain autoimmune disorders driven by excessive B-cell activity. Earlier this year, Autolus began an open-label Phase 1 study evaluating Aucatzyl in systemic lupus erythematosus. Autolus has said that depending on the outcome of this test, it could proceed to further studies in lupus and lupus nephritis among other autoimmune disorders.</p> <div class="ad ad--inline_bottom ad--format-square ad--mobile-only" id="ad--inline_bottom inline_bottom"> <div class="ad__wrapper"> <div id="ad-inline_bottom"></div> </div> </div><p>In the nearer term, Autolus is focusing on commercialization of Aucatzyl in ALL. An Autolus manufacturing facility in Stevenage, United Kingdom, will produce the therapy for global markets. The therapy is still under regulatory review in Europe. Cardinal Health is the distribution partner for the product in the U.S.</p> <p>Aucatzyl enters an ALL market dominated by Amgen’s Blincyto, a bispecific antibody designed to target CD19 on B cells and CD3 on T cells. This drug is approved for treating ALL in adults and pediatric patients. Amgen reported <a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/318154/000031815424000011/amgn-20231231.htm" target="_blank" rel="noopener">$861 million in 2023 sales</a> for the product, a 48% year-over-year increase. But this drug’s label carries a black box warning for cytokine release syndrome and neurotoxicity. It also offers limited durability. Meanwhile, Tecartus is not a big revenue generator for Gilead, but sales are growing. For 2023, the company <a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/882095/000088209524000007/gild-20231231.htm" target="_blank" rel="noopener">reported $370 million</a> in global Tecartus sales, a nearly 23.7% increase compared to the same period in in the prior year. Novartis’s CD19-targeting CAR T-therapy, Kymriah, is approved for treating ALL in patients up to age 25.</p> <p>[<em>Paragraph updated with additional analyst commentary.</em>] In a Monday research note, William Blair’s Phipps said the lack of a REMS requirement removes administrative and logistical burdens from the sites that administer Aucatzyl as well as training requirements, which could result in a faster ramp-up of the therapy. Aucatzyl carries a $525,000 wholesale price, reflecting the therapy’s clinical evidence, differentiated safety, and economic value, Autolus said in an <a href="https://autolus.gcs-web.com/static-files/620409a6-9f81-4834-a9ad-a92c58784ea8" target="_blank" rel="noopener">investor presentation</a>. That price represents a roughly 11% premium to Tecartus’s list price in adult ALL. While William Blair initially expected the Autolus drug’s price would be in line with the Gilead product, Phipps said Aucatzyl’s differentiation on safety and REMS reporting warrants a premium price point. Aucatzyl costs less than the $580,000 price of Novartis’s Kymriah. Phipps noted drugs approved for the pediatric setting typically carry higher prices.</p> <p><em>Image: Getty Images</em></p> </div> </div> <footer class="post-single__footer"> <div class="post-single__topics"> <h2 class="post-single__topic-title">Topics</h2> <ul class="post-single__tags list-none"> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/acute-lymphoblastic-leukemia/ " rel="tag">acute lymphoblastic leukemia</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/aucatzyl/ " rel="tag">Aucatzyl</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/autolus-therapeutics/ " rel="tag">Autolus Therapeutics</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/blood-cancer/ " rel="tag">blood cancer</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/cancer/ " rel="tag">cancer</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/car-t/ " rel="tag">CAR-T</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/cell-therapy/ " rel="tag">cell therapy</a> </li> <li class="post-single__tag-item"> <a class="post-single__tag" href="https://medcitynews.com/tag/fda/ " rel="tag">FDA</a> </li> </ul> </div> <section class="newsletter-signup form-interruptor"> <header class="newsletter-signup__header"> <h2 class="newsletter-signup__title"> MedCity News Daily Newsletter </h2> <h3 class="newsletter-signup__subtitle"> Sign up and get the latest news in your inbox. </h3> </header> <form class="newsletter-signup__form" data-hs-cf-bound="true"> <div class="newsletter-signup__field-group"> <label for="newsletter-signup-email" class="visually-hidden">Enter your email address</label> <input id="newsletter-signup-email" class="newsletter-signup__field newsletter-signup__field--email" type="email" name="email" placeholder="Enter your email address"> <button class="newsletter-signup__submit">Subscribe Now</button> </div> </form> <footer class="newsletter-signup__footer"> <p class="newsletter-signup__disclaimer"> We will never sell or share your information without your consent. 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