Business Wire

Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3 -ITD Positive AML


Daiichi Sankyo (TSE: 4568) announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the phase 3 QuANTUM-First trial, which were published in The Lancet. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

In QuANTUM-First, quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival was 31.9 months for patients receiving quizartinib (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

“Today’s positive CHMP opinion for quizartinib is an important step towards translating the clinical benefit observed in QuANTUM-First into an approved treatment option for patients in the EU with the difficult-to-treat FLT3-ITD subtype of acute myeloid leukemia,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “If approved, quizartinib would be the first FLT3 inhibitor approved specifically for patients with newly diagnosed FLT3-ITD positive AML.”

The safety profile of quizartinib in QuANTUM-First was consistent with previous clinical trials with no new safety signals observed. The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%). QTcF > 500 ms occurred in 2.3% of patients receiving quizartinib and 0.8% of patients discontinued quizartinib due to QT prolongation. Ventricular arrhythmia events with quizartinib were uncommon. Two (0.8%) patients receiving quizartinib experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

About QuANTUM-First
QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating quizartinib in combination with standard induction and consolidation therapy, including HSCT, and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive quizartinib or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance.

The primary study endpoint was overall survival. Secondary endpoints include event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR were also evaluated.

QuANTUM-First enrolled 539 patients at 193 study sites in 26 countries across Asia, Europe, North America, Oceania and South America. For more information, visit

About FLT3-ITD Positive Acute Myeloid Leukemia
More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.1 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.2,3 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients.4,5

A number of gene mutations have been identified in AML, and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.6 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.6,7 FLT3-ITD mutations occur in about 25% of all AML cases, with frequency reported as high as 30%.6,7

About Quizartinib
Quizartinib is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.6

Quizartinib is approved in the U.S. in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test. Quizartinib is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with quizartinib in this setting has not been demonstrated.

Quizartinib also is approved in Japan for the treatment of AML that is FLT3-ITD mutation positive, including for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy for adult patients with newly diagnosed FLT3-ITD positive AML, and as a monotherapy for relapsed/refractory AML that is FLT3-ITD positive as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan and the U.S.

About the Quizartinib Clinical Development Program
The quizartinib clinical development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center.

About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit


1 Global Cancer Observatory. Population Fact Sheet: World. Updated March 2021.
2 American Cancer Society: Key Statistics for Acute Myeloid Leukemia. Updated January 2023.
3 Dong Y, et al. Exp Hematol Oncol. (2020);9:14.
4 Rodriguez-Abreu D, et al. Ann Oncol (2007);18 Suppl 1:i3-i8.
5 Heuser M, et al. Ann Oncol. (2020) 31(6):697-712.
6 Daver N, et al. Leukemia. (2019) 33:299-312.
7 Patel JP, et al N Engl J Med. (2012) Mar 22;366(12):1079-89.

To view this piece of content from, please give your consent at the top of this page.

Contact information

Jennifer Brennan
Daiichi Sankyo, Inc.
+ 1 908 900 3183 (mobile)

Simone Jendsch-Dowé
Daiichi Sankyo Europe GmbH
+49 (89) 7808437 (office)
+49 176 11780822 (mobile)

Koji Ogiwara
Daiichi Sankyo Co., Ltd.
+81 3 6225 1126 (office)

Investor Relations Contact:

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Monument Re Limited Announces Key Staffing Changes4.10.2023 18:00:00 CEST | Press release

Monument Re Limited (“Monument Re”) announced today that Manfred Maske has stepped down from his role as Group CEO effective from 19th September 2023. Jonathan Yates, Chairman of Monument Re, stated that “Manfred joined Monument Re Group in February 2017, when the company was a relatively new venture. Over 6 years of dedicated service, Manfred has played an integral role in creating the market leading business that it is today. Together with the Senior Leadership Team, I would like to thank Manfred for his leadership, commitment, dedication and invaluable contribution to the creation of the Monument Re Group. We wish Manfred the best of success in his future endeavours”. Monument further announced that Carlo Elsinghorst has been appointed as Group CEO. Carlo joined Monument in 2020 as CEO Ireland and was appointed Group CFO in April 2022. During his time at Monument, Carlo successfully led the Irish team through a series of domestic acquisitions and the growing maturity of the organisa

Linksys Announces Global Expansion with Additional Offices4.10.2023 18:00:00 CEST | Press release

Linksys, an iconic Home and Small Office connectivity company, announces plans to expand globally with a development location in Taipei, Taiwan, and a new Sales and Marketing location in Amstelveen, Netherlands. Linksys is reasserting itself in both the Residential Retail and Residential Service Provider markets, which has driven the need to expand beyond its Irvine, California headquarters of 35+ years. The new offices will be near the major technology hubs of both countries and are also in close proximity to several universities that offer the talent necessary for Linksys to drive its growth targets over the next five years and beyond. “It’s a big world out there, and it is long overdue that Linksys push out beyond our Irvine, California headquarters and create anchor offices in other regions where we expect to grow in the coming years,” said Linksys CEO Jonathan Bettino. “Although we work from home quite a lot, having an office to go to a couple of times a week helps build teamwork

FPT Software’s MaaZ Wins AutoTech Breakthrough “Overall Connected Solution of the Year”4.10.2023 16:30:00 CEST | Press release

FPT Software’s MaaZ was recently awarded the “Overall Connected Solution of the Year” at the fourth annual AutoTech Breakthrough Awards in first-time nomination. This recognition underscores the IT services provider's robust automotive tech competency in the software-defined vehicle era. This press release features multimedia. View the full release here: (Graphic: Business Wire) Conducted by Tech Breakthrough, the annual AutoTech Breakthrough Awards program is the industry’s most comprehensive analysis and evaluation to recognise top companies, technologies and products in today's global automotive and transportation technology markets. Surpassing more than 1,600 nominations from over 15 countries, FPT Software's MaaZ is the only solution named the “Overall Connected Solution of the Year.” Launched in 2022, MaaZ is a comprehensive connected car solution aiming to assist worldwide automotive suppliers and car OEMs to tackle the c

Xsolla Powers Web Shop Launches for 40 of the Top 100 Mobile Games4.10.2023 16:00:00 CEST | Press release

Xsolla, a global video game commerce company, shares insights that 40 of the top 100 mobile games have launched their Web Shop using Xsolla's solution. These insights offer a glimpse into the increasing trend of multiplatform operations in the mobile gaming industry for 2023 and entering 2024. Based on Xsolla’s research and analysis, they have assisted 151 games in launching Web Shops this year. This achievement reflects the mobile gaming landscape's transformation, with a move towards cross-platform integration. This press release features multimedia. View the full release here: Xsolla Web Shop (Graphic: Business Wire) "With the support of Xsolla, is shedding light on the growing need for a connective platform in the gaming industry," said Kirill Tokarev, CEO of "This concept aims to provide equal opportunities for gaming and porting studios, particularly those with limited internal capacity, by connecting them wit

New Research: A Quarter of US Network Engineers Are Set to Retire in Five Years4.10.2023 15:00:00 CEST | Press release

According to new research released today by Opengear, a Digi International company (NASDAQ, DGII, and provider of secure and SmartOut of Bandmanagement solutions, 86% of U.S.-based CIOs surveyed expect at least 25% of their network engineers to retire in the next five years. The networking industry is facing a skills shortage as engineers continue retiring. Almost every CIO (95%) surveyed said that a shortfall in engineers has led to an inability to manage networks, and 91% of U.S. engineers and 81% of global engineers surveyed agree with this. Additionally, 79% of U.S. CIOs state that they are now struggling to meet user or customer expectations in today’s economic environment. The Opengear study surveyed 502 CIOs and 510 network engineers across the U.S., U.K., France, Germany and Australia. It shows that 98% of U.S. engineers surveyed have been forced to achieve more with fewer resources over the past three months, which is even higher than those in the U.K. (88%) and