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Natera Acquires Foresight Diagnostics

On December 5, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Foresight Diagnostics, a leader in ultrasensitive molecular residual disease (MRD) detection, reported that Natera has completed a transaction to acquire Foresight.

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Foresight is a cancer diagnostics company and CLIA-registered laboratory. The company’s circulating tumor DNA (ctDNA)-based MRD tests leverage its patented PhasED-Seq technology, targeting phased variants. With this technology, Foresight has reported performance with LOD95 of 0.3 parts per million and detection below 0.1 ppm1.

Foresight was founded by Stanford University physicians and scientists, Maximilian Diehn, M.D., Ph.D., Ash Alizadeh, M.D., Ph.D., and David Kurtz, M.D., Ph.D., together with Jake Chabon, Ph.D., Foresight’s chief scientific officer and chief executive officer. The company has authored more than 40 scientific publications and presentations and partnered with more than 30 biopharma and academic researchers.

Strategic Rationale

The transaction combines Natera’s leading commercial and operational infrastructure for the delivery of personalized MRD testing with Foresight’s unique phased variant technology and leadership in lymphoma. It builds on Natera’s broad intellectual property portfolio for tumor-informed and personalized MRD products including in phased variants, and promises to accelerate MRD adoption in lymphoma and other solid tumor types.

Signatera platform with phased variants: The integration of phased variants into the Signatera platform will further differentiate and strengthen test performance across solid tumors. This enhanced version is available immediately for research use for biopharma and academic partners and is expected to be launched for clinical use in 2026.
Leadership in lymphoma: The transaction builds on Foresight’s clinical research momentum in B-cell lymphomas, a large patient population with more than 75,000 new cases annually in the U.S.2 Earlier this year, Foresight data provided the foundation for the inclusion of ctDNA MRD into the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for diffuse large B-cell lymphoma. Additionally, Foresight’s CLARITY MRD assay for lymphoma is being used in three prospective MRD-driven clinical trials informing treatment decisions for patients. Foresight CLARITY joins Natera’s extensive MRD product portfolio and will continue to support clinical trials, translational research and future applications.
At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting beginning on December 6, Natera and Foresight will have a total of 15 abstracts featuring Signatera and PhasED-Seq, including seven oral presentations.

Transaction Terms

Natera has closed the acquisition of Foresight in an all-stock transaction consisting of a $275 million upfront with an additional $175 million in earnouts tied to the achievement of revenue- and reimbursement-based milestones.

"This acquisition reinforces Natera’s position at the forefront of precision oncology," said Steve Chapman, chief executive officer of Natera. "Foresight’s phased variant technology and leadership in lymphoma complement Natera’s strong capabilities in personalized MRD testing, improving the value we can deliver to patients, clinicians, biopharma partners and the broader healthcare system."

"Foresight’s mission has always been to improve the lives of cancer patients worldwide through innovative diagnostics," said Chabon. "As we join Natera, I’m deeply grateful to our employees, partners and investors who have helped bring us to this moment. Together, we can realize this mission on a far greater scale, accelerating the pace of discovery across both hematologic and solid tumors."

Gibson, Dunn & Crutcher LLP is serving as legal counsel to Natera. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Foresight, while Centerview Partners LLC is acting as its financial advisor.

(Press release, Natera, DEC 5, 2025, View Source [SID1234661181])

Guardant Health to Present 14 Abstracts Demonstrating the Power of Multiomic Liquid Biopsy Tests in Predicting Outcomes and Tailoring Treatment for Early and Metastatic Breast Cancer at the 2025 San Antonio Breast Cancer Symposium

On December 5, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present a total of 14 abstracts with its research collaborators from multiple studies demonstrating the value of its tissue-free liquid biopsy tests at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 9–12, 2025.

Oral presentations will highlight results generated with Guardant Reveal, the company’s tissue-free test for detecting minimal residual disease (MRD) and Guardant360 Liquid, the company’s comprehensive multiomic profiling test, both leveraging Guardant’s proprietary epigenomic technology powered by the Guardant Infinity Smart Platform. Collectively, these studies demonstrate how blood-based testing can uncover risk, guide treatment selection, and influence long-term patient management across the breast cancer continuum, from early-stage disease through metastatic settings.

Guardant’s MRD presentations reinforce the value of tissue-free circulating tumor DNA (ctDNA) testing for both neoadjuvant treatment response assessment and post-treatment surveillance in early-stage breast cancer. In a retrospective analysis of HER2-positive patients, ctDNA measured with Guardant Reveal demonstrated strong prognostic significance in the neoadjuvant setting, showing a correlation with pathological complete response and three-year invasive disease-free survival. In an independent study of triple-negative breast cancer patients, Guardant Reveal accurately predicted relapse risk and detected ctDNA more frequently and earlier than orthogonal methods.

Together, these findings demonstrate the validity of Guardant Reveal as a reliable approach for ctDNA detection and monitoring in both neoadjuvant and surveillance settings.

"Breast cancer care increasingly depends on understanding tumor biology at every stage of disease, and Guardant’s data continues to reaffirm the growing value of multiomic liquid biopsy as a powerful, non-invasive tool to equip providers with the data necessary to tailor therapy and treatment," said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. "We look forward to sharing our findings demonstrating the power of blood in helping provide clinicians with deeper clarity and more confident decision-making for their patients."

Other data highlights to be presented include:

Data showcasing the clinical utility of Guardant Reveal in predicting outcomes in patients with early-stage HER2-positive breast cancer. In this analysis, early ctDNA clearance throughout treatment was linked to better outcomes, underscoring ctDNA as a sensitive marker of treatment response and highlighting the value of tissue-free testing for real-time response monitoring.
Data supporting the clinical value potential of non-invasive, methylation-based, continuous breast cancer subtype monitoring by Guardant360 Liquid to uncover tumor evolution and heterogeneity that may guide more precise treatment decisions. In this analysis, Guardant360 Liquid showed agreement to tissue-based monitoring and replicated previously reported accuracy.
Data showcasing Guardant360 Liquid methylation-based breast cancer subtyping feature as a noninvasive liquid tool to dynamically reassess ER, HER2 and triple negative status in patients who are resistant to ER therapy but don’t carry an ESR1 mutation. In this study, Guardant360 Liquid predicted real-world outcomes in previously AI-treated patients receiving subsequent lines of therapy.
Guardant-Led Research at SABCS 2025

Presentation

Title

Time / Location

Wednesday, December 10

PD2-09

Molecular Evolution in Early and Late-Stage Tumors

7:00 – 8:30am CST / 301 ABC

GS1-07

Circulating tumor DNA (ctDNA) in human epidermal growth factor receptor

9:30am – 12:00pm / Hall 1

PS1-12-05

Liquid biopsy–based molecular profiling using GUARDANT360 CDx at progression on CDK4/6i+ET: findings from the AGO-B CAPTOR study

12:30pm – 2:00pm / Exhibit Hall

PS1-11-09

Real-world prevalence of estrogen receptor (ER) 1 mutations (ESR1m) among patients with ER+/ human epidermal growth factor receptor 2 (HER2)− metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or cyclin dependent kinase 4/6 inhibitors (CDK4/6i)

12:30pm – 2:00pm / Exhibit Hall

RF3-05

Tissue-free circulating tumor DNA detection in patients with early triple negative breast cancer from the c-TRAK-TN trial

12:30pm – 2:00pm / Exhibit Hall

PS2-07-02

Tissue-free epigenomic circulating tumor DNA (ctDNA) analysis pre- and post-surgery in early breast cancer: clinical features and prognostic utility

4:30pm – 5:30pm / Stars at Night

PS2-07-18

Prognostic effects of methylation-based HR and HER2 assessments by liquid biopsy in ESR1 mutation negative advanced breast cancer

4:30pm – 5:30pm / Stars at Night

PS2-07-16

Clinicogenomic characterization and ctDNA detection of ESR1 fusion positive metastatic breast cancer

5:00pm – 6:30pm / Exhibit Hall

PS2-09-21

Real-world clinical outcomes and genomic insights for patients with PIK3CA-mutant metastatic breast cancer following progression on CDK4/6 inhibitor therapy

5:00pm – 6:30pm / Exhibit Hall

PS2-08-17

Prevalence and clinical significance of exon 6 ESR1 gene fusions in advanced breast cancer after disease progression on aromatase inhibitors

5:00pm – 6:30pm / Exhibit Hall

PS2-10-19

Circulating tumor DNA (ctDNA) as a strong prognostic biomarker of minimal residual disease (MRD) using a tissue-free, epigenomic assay in early-stage breast cancer.

5:00pm – 6:30pm / Exhibit Hall

Thursday, December 11

PD9-03

Comprehensive genomic profiling and clinically targetable mutations of metastatic invasive lobular and no special type breast cancer

7:00am – 8:30am / Hemisfair Ballroom

PS4-01-11

Exploration of racial differences in variants of uncertain significance (VUS), ESR1 and PIK3CA mutation frequency, matched therapy use, and outcomes in metastatic breast cancer (mBC)

7:00am – 8:30am / Hemisfair Ballroom

PS4-02-10

Agreement of cell-free DNA methylation-based molecular breast subtyping and tissue subtyping in hormone receptor positive metastatic breast cancer: a clinical cohort analysis

5:00pm – 6:30pm / Exhibit Hall

The full abstracts for Guardant Health and a list of all abstracts being presented at SABCS 2025 can be found on the SABCS website.

For information and updates from the conference, visit booth #942 and follow Guardant Health on LinkedIn, X (Twitter) and Facebook.

(Press release, Guardant Health, DEC 5, 2025, View Source [SID1234661180])

IceCure Receives Notice of Patent Allowance in China for a Novel Cryogen Flow Control to Optimize Patient Cryoablation Outcomes

On December 5, 2025 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported it received a Notice of Allowance for a patent from the China National Intellectual Property Administration for its invention titled "Cryogen Flow Control" which relates to its next-generation XSense cryoablation system and probes.

A patent for this invention has been granted in Japan and is currently pending approval in the European Union, the U.S., and other major markets.

"We believe IceCure’s commitment to technology innovation and our drive to make a significant impact on patient outcomes has resulted in our intellectual property portfolio in cryoablation reaching 55 patents granted and allowed across the globe," said Eyal Shamir, IceCure’s Chief Executive Officer. "Our cryoablation systems and probes already have regulatory approval in China for indications including breast cancer, and we continue to innovate next-generation liquid nitrogen-based systems including XSense to further improve patient outcomes."

The notice of allowance for the patent addresses precise temperature control, which is crucial for efficacy and tissue safety in cryoablation procedures. Cryogenic flow control achieves this by utilizing sensor data to regulate the flow of cryogens, ensuring the desired temperature is reached and maintained at the distal tip of catheters and probes. This optimized cryogenic delivery enhances treatment effectiveness in cryoablation procedures. Advanced cryogen flow control systems may also offer functionalities, such as navigation and mapping support within the patient’s anatomy, and be incorporated into a wide range of cryosurgical tools.

The ProSense Cryoablation System is the first and only medical device to receive U.S. Food and Drug Administration ("FDA") marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and older, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website. XSense is the Company’s next-generation cryoablation system.

(Press release, IceCure Medical, DEC 5, 2025, View Source [SID1234661179])

Blueprint Medicines, a Sanofi Company, Highlights Long-Term Clinical Benefit of AYVAKIT® (avapritinib) Across Indolent and Advanced Systemic Mastocytosis at 2025 ASH Annual Meeting

On December 5, 2025 Blueprint Medicines, a Sanofi company, reported updated data reinforcing the clinical efficacy and safety of long-term AYVAKIT (avapritinib) use across the spectrum of systemic mastocytosis (SM), including indolent and advanced SM. AYVAKIT led to sustained symptom and quality-of-life benefits in indolent SM (ISM) after a median follow-up of more than three years, and extended survival rates in advanced SM after a median follow-up of more than four years. Across both forms of SM, AYVAKIT showed bone health improvements reflecting disease-modifying effects, and a safety and tolerability profile consistent with previously reported results. As part of its ongoing leadership to improve SM care, Blueprint Medicines will report one oral presentation and seven poster presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 6–9 in Orlando, Florida.

"Our ASH (Free ASH Whitepaper) data add to the substantial body of evidence generated since we initiated clinical development for systemic mastocytosis about a decade ago, and reflect the transformative benefits AYVAKIT has delivered since its FDA approval for advanced SM in 2021 and ISM in 2023," said Mik Rinne, M.D., Ph.D., Head of Development at Blueprint Medicines. "AYVAKIT has become the global standard of care across the spectrum of the disease, with robust datasets highlighting sustained quality-of-life benefits in ISM, favorable survival outcomes in advanced SM and a well-characterized safety profile supporting chronic treatment. Our presentations reinforce the urgency to treat the root cause of SM to mitigate its significant health complications and underscore the role of AYVAKIT as a best-in-class therapy for the long-term management of the disease."

PIONEER: Durable Symptom Control, Quality-of-Life Benefits and Bone Health Improvements in ISM, with a Multi-Year Safety Profile Similar to the 24-Week Placebo-Controlled Portion of the Trial (Poster Presentations; Abstract Numbers 2024, 5582)

In patients with ISM (N=226), AYVAKIT showed sustained improvements in overall symptoms, all symptom domains (skin, gastrointestinal, neurocognitive) and most severe symptom per the ISM Symptom Assessment Form (ISM-SAF), and in quality of life per the Mastocytosis Quality of Life Questionnaire (MC-QoL).
AYVAKIT led to durable benefits in bone health among patients receiving dual-energy X-ray absorptiometry (DXA) scans (n=79), independent of concomitant use of other treatments known to improve bone density.
With a median follow-up of more than three years, the overall trial population had a 3 percent discontinuation rate due to treatment-related adverse events (TRAEs), reflecting a best-in-class safety and tolerability profile. Edema was the most common TRAE, and the majority of these events were mild (Grade 1).
PATHFINDER: Prolonged Survival, Robust Clinical Responses and Improved Bone Health with a Consistent Safety Profile Over Time in Advanced SM (Oral Presentation; Abstract Number 1022)

In patients with advanced SM receiving first-line AYVAKIT (n=38), the median overall survival (OS) was not reached and the OS rate at 48 months was 79 percent after a median follow-up of more than four years, reflecting sustained clinical benefit.
Historically, advanced SM has been associated with poor survival.1,2 In a prior clinical trial of midostaurin, the median OS was 28.7 months for patients with advanced SM.1
In treatment-naïve patients who were response evaluable (n=30), the overall response rate (ORR) was 87 percent, and the rate of complete remissions with full or partial hematologic recovery (CR/CRh) was 43 percent.
Among patients receiving DXA scans across lines of therapy (n=56), 21 percent had low bone density at baseline. In this population, AYVAKIT significantly increased bone density versus baseline levels (p<0.05).
In patients across lines of therapy (N=107), AYVAKIT had a favorable benefit/risk profile consistent with previously reported data. Common TRAEs were edema (periorbital and peripheral), thrombocytopenia and anemia.
PATHFINDER: Survival Benefits in Intermediate- and High-Risk Patients with Advanced SM, a Historically Underserved Population (Poster Presentation; Abstract Number 5595)

This analysis included patients with advanced SM who had intermediate- and high-risk prognostic scores at baseline, as determined by the Mutation-Adjusted Risk Score (MARS).
In the treatment-naïve setting, PATHFINDER results for AYVAKIT (n=24) were indirectly compared to real-world data for midostaurin (n=43), and statistical methods were used to adjust for baseline demographic differences between the two patient populations.
AYVAKIT was associated with improved OS relative to midostaurin (Hazard Ratio [HR]: 0.08; p<0.001) in these patients, who have traditionally had the worst prognosis.
Data Presentations

Oral Presentation: Avapritinib Treatment of Patients with Advanced Systemic Mastocytosis: 4-Year Safety, Effect on Bone and First-Line Efficacy Results of the PATHFINDER Clinical Study (Abstract #1022 – Monday, December 8)
Poster Presentation: Avapritinib Achieves Deep and Durable Symptom Control with a Well-Tolerated Safety Profile in ISM: Long-Term Outcomes from PIONEER (Abstract #2024 – Saturday, December 6)
Poster Presentation: Effect of Avapritinib on Skin Lesions in Patients with Advanced Systemic Mastocytosis Using a Novel, Artificial Intelligence-Based Technology (PATHFINDER) (Abstract #2030 – Saturday, December 6)
Poster Presentation: Changes in Long-Term Bone Health in Patients Receiving Avapritinib for the Treatment of Indolent Systemic Mastocytosis in the PIONEER Study (Abstract #5582 – Monday, December 8)
Poster Presentation: Improved Overall Survival in Patients with Advanced Systemic Mastocytosis Treated with Avapritinib Versus Real-World Therapy Based on Mutation-Adjusted Risk Score (MARS) Stratification (Abstract #5595 – Monday, December 8)
Poster Presentation: An Analysis of Clonal Dynamics in Patients with Indolent Systemic Mastocytosis Treated with Avapritinib in the PIONEER Study (Abstract #5573 – Monday, December 8)
Poster Presentation: Diagnostic Evolution in Systemic Mastocytosis: Clinical Impact of WHO 2022 Criteria on Smoldering Systemic Mastocytosis Identification in PIONEER (Abstract #5578 – Monday, December 8)
Poster Presentation: Interpreting Tryptase Levels and Avoiding Common Pitfalls in Screening for Clonal Mast Cell Disease (Abstract #4774 – Monday, December 8)
At the start of its oral session and at 8:00 a.m. ET on the day of their respective poster sessions, data presentations will be available in the "Science―Publications and Presentations" section of Blueprint Medicines’ website, www.blueprintmedicines.com.

About Systemic Mastocytosis

Systemic mastocytosis (SM) is a rare disease driven by the KIT D816V mutation in about 95 percent of cases. Uncontrolled proliferation and activation of mast cells result in chronic, severe and often unpredictable symptoms across multiple organ systems. The vast majority of those affected have indolent systemic mastocytosis (ISM). Despite treatment with multiple symptom-directed therapies, patients with ISM frequently experience persistent symptoms including anaphylaxis, maculopapular rash, pruritus, diarrhea, brain fog, fatigue and bone pain, as well as long-term health complications such as osteoporosis. This burden of disease can lead to a profound, negative impact on quality of life. Patients often live in fear of severe, unexpected symptoms, have limited ability to work or perform daily activities, and isolate themselves to protect against unpredictable triggers. There were no approved therapies for ISM until 2023, when AYVAKIT received U.S. Food and Drug Administration (FDA) approval for this indication.

A minority of patients have advanced SM, which encompasses a group of high-risk SM subtypes including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL). In addition to mast cell activation symptoms, advanced SM is associated with organ damage due to mast cell infiltration – including bone lesions, malabsorption, liver dysfunction and bone marrow failure – as well as poor overall survival.

(Press release, Blueprint Medicines, DEC 5, 2025, View Source [SID1234661178])

Astellas To Present New Data on XOSPATA™ (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting

On December 5, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that new data evaluating XOSPATA (gilteritinib) across FMS-like tyrosine kinase 3 mutation-positive (FLT3m+) acute myeloid leukemia (AML), including in relapsed or refractory (R/R), newly diagnosed and post-transplant maintenance settings, will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place from 6-9 December 2025 in Orlando, Fla.

Through ongoing research with gilteritinib, Astellas is advancing the science of FLT3m+ AML and generating new evidence across the disease stages, to help improve long-term outcomes for people diagnosed with FLT3m+ AML.

Highlights from Astellas at ASH (Free ASH Whitepaper) 2025 will include:

A pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE trials evaluating gilteritinib in R/R FLT3m+ AML, exploring treatment sequencing and resumption post-transplant to improve outcomes.
In collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), data from a post-hoc analysis of the Phase 3 MORPHO study examining how time from diagnosis to transplant, use of FLT3 inhibitors before transplant and use of gilteritinib post-transplant influenced outcomes in FLT3m+ AML.
Results from the ongoing Phase 1/2 VICEROY study (NCT05520567) investigating triplet combination therapy approach including gilteritinib in newly diagnosed FLT3m+ AML patients ineligible for intensive chemotherapy, focused on safety, efficacy and dosing optimization.
Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas
"Building on gilteritinib’s foundation in treating relapsed or refractory FLT3-mutated AML – one of the most challenging forms of leukemia characterized by high rates of treatment failure and relapse – Astellas is dedicated to advancing research that provides valuable insights to inform clinical practice. This new data exemplifies our ‘bench to bedside’ approach, translating scientific innovation into VALUE for patients who urgently need new treatment options."

Astellas Presentations at ASH (Free ASH Whitepaper) 2025

Presentation Title

Presenter

Presentation Details

Outcomes of patients with
relapsed/refractory FLT3mut+
Acute Myeloid Leukemia who
resumed gilteritinib therapy after
HSCT: Post hoc analysis from the
ADMIRAL and COMMODORE
trials

J. Wang

Type: Oral

Presentation ID: 45

Date: December 6, 10:45 – 11:00 EST

Venetoclax (VEN) and azacitidine
(AZA) with gilteritinib (GILT) in
patients with newly diagnosed (ND)
FLT3mut+ Acute Myeloid
Leukemia (AML) ineligible for
intensive induction chemotherapy
(chemo): Interim results from the
phase 1/2 VICEROY study

J. Altman

Type: Oral

Presentation ID: 654

Date: December 7, 17:45 – 18:00 EST

Time from AML diagnosis to HCT
and pre-HCT FLT3 inhibition
impact pre-transplant MRD and
benefit from post-HCT gilteritinib

(In collaboration with BMT CTN)

M. Levis

Type: Oral

Presentation ID: 1058

Date: December 8, 16:45 – 17:00 EST

A Phase 2 study of sequential
administration of gilteritinib after
MEC chemotherapy in
Relapsed/Refractory FLT3-mutated
Acute Myeloid Leukemia in adults:
Japan adult leukemia study group
(JALSG) RR-FLT3-AML220 study

Y. Ishikawa

Type: Oral

Presentation ID: 998

Date: December 8, 16:45 – 17:00 EST

Transfusion burden among older
US patients with relapsed FLT3-
mutated Acute Myeloid Leukemia
treated with gilteritinib: A Medicare
claims-based cohort study

T. LeBlanc

Type: Poster

Presentation ID: 1664

Date: December 6, 17:30 – 19:30 EST

Maintenance treatment with
gilteritinib suppresses post-
transplant relapse in
relapsed/refractory FLT3-mutated
acute myeloid leukemia: A
Japanese nationwide registry study

Y. Arai

Type: Poster

Presentation ID: 4289

Date: December 7, 18:00 – 20:00 EST

Investigator Sponsored Research Presentations at ASH (Free ASH Whitepaper) 2025

Presentation Title

Presenter

Presentation Details

Long-term follow-up of azacitidine,
venetoclax, and gilteritinib in
patients with newly diagnosed
FLT3-mutated Acute Myeloid
Leukemia

RS. Azevedo

Type: Oral

Presentation ID: 45

Date: December 6, 10:00 – 10:15 EST

A phase II study of azacitidine,
venetoclax, and gilteritinib for
newly diagnosed adverse risk
FLT3-wild type acute myeloid
leukemia

S. Arora

Type: Poster

Presentation ID: 5226

Date: December 8, 18:00 – 20:00 EST

Gilteritinib is a FLT3 inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-tyrosine kinase domain (TKD) mutations.1 Gilteritinib is available as XOSPATA across the world, including in the U.S., Japan, China and multiple European countries for the treatment of adult patients who have relapsed or refractory FLT3m+ AML.

The ongoing, randomized, multicenter, open-label, Phase 3 PASHA study (NCT04027309) is evaluating gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one year of maintenance in patients with newly diagnosed FLT3-mutated AML eligible for intensive chemotherapy.

About Gilteritinib
Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-TKD mutations.1 It was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global development, commercialization and manufacturing rights to gilteritinib.2

Gilteritinib was evaluated in ADMIRAL (NCT02421939), a Phase 3, open-label, multicenter, randomized clinical trial comparing gilteritinib with prespecified salvage chemotherapy in adult patients with relapsed or refractory FLT3-mutated AML.

About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is an aggressive cancer that affects the bone marrow and blood, and its incidence increases with age.3,4 Of patients newly diagnosed with AML and tested for FLT3 mutations, approximately one-third have an alteration to the FLT3 gene. FLT3-ITD mutations have been associated with worsened disease-free survival and overall survival, and a higher risk of getting the disease more than once. FLT3 mutation status can change over the course of AML treatment, even after relapse.

(Press release, Astellas, DEC 5, 2025, View Source [SID1234661177])