On October 16, 2025 Cycle Pharmaceuticals reported the launch of PHYRAGO, its first oncology product in the US. PHYRAGO is launched in partnership with Handa Therapeutics, LLC, and will be exclusively available through specialty pharmacy Onco360 with a specialty distribution network from McKesson, Cencora, and Cardinal Health.

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PHYRAGO is a tyrosine kinase inhibitor indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and pediatric patients 1 year of age and older with Ph+ CML in chronic phase, and newly diagnosed Ph+ ALL.1

PHYRAGO is bioequivalent to Sprycel (dasatinib) tablets,2 and has the unique clinical benefit of allowing patients to take proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) concomitantly to help manage gastric acid disorders.1 To help patients with medication access, financial savings, and clinical support, Cycle Vita will be available to eligible* patients taking PHYRAGO.†

"We are honored to introduce PHYRAGO as a new treatment option for people living with Ph+ leukemia," said Steve Fuller, Chief Strategy Officer at Cycle Pharmaceuticals.

"We understand the daily challenges that come with managing Ph+ CML and Ph+ ALL, and our goal is to ease that burden, not just with an improved formulation of dasatinib, but through the individualized care and hands on support offered by our Cycle Vita program. By enabling more flexibility in co-medication and providing a dedicated support team, we’re committed to helping patients and their families navigate treatment with greater confidence and peace of mind."

Cycle Pharmaceuticals has been empowering patients with rare diseases through its products and support hub since 2017.

NITYR (nitisinone) Tablets in 2017
SAJAZIR (icatibant) Injection in 2021
JAVYGTOR (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution in 2022
TASCENSO ODT (fingolimod) in 2023
ORMALVI (dichlorphenamide) tablets in 2024
VENXXIVA (tiopronin) Delayed-Release Tablets in 2025
BAFIERTAM (monomethyl fumarate) Delayed-Release Capsules in 2025
HARLIKU (nitisinone) Tablets in 2025
Indications

PHYRAGO is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance / intolerance to prior therapy including imatinib.
Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance / intolerance to prior therapy.
Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
Important Safety Information

Warnings and Precautions:

Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor blood counts. Transfuse and interrupt PHYRAGO when indicated.

Fluid Retention: Fluid retention, including pleural effusions. Manage with supportive care and/or dose modification.

Cardiovascular Toxicity: Monitor for signs or symptoms and treat appropriately.

Pulmonary Arterial Hypertension (PAH): PHYRAGO may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop PHYRAGO if PAH is confirmed.

QT Prolongation: Use PHYRAGO with caution in patients who have / may develop prolongation of the QT interval.

Severe Dermatologic Reactions: Severe mucocutaneous dermatologic reactions have been reported.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain hydration and correct uric acid levels prior to initiating treatment.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception.

Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development.

Hepatotoxicity: Assess liver function before treatment, monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy.

Adverse Reactions:

Common adverse reactions in adults include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

Common adverse reactions in pediatric patients include mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

Postmarketing Experience:

Post approval adverse reactions:

Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity.

Drug Interactions:

Strong CYP3A4 Inhibitors and Strong CYP3A4 Inducers: Dose reduction may be necessary.

Antacids: Avoid concomitant use.

Use in Specific Populations:

Pregnancy: PHYRAGO can cause fetal harm. Advise a pregnant woman of the potential risk to a fetus.

Contraception: Should be used during treatment and for 30 days after the last dose.

Lactation: Breastfeeding is not recommended during treatment and for 2 weeks after the last dose.

Pediatric Use: There is no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported and should be monitored closely. Refer to the full USPI for pediatric patients with difficulty swallowing tablets.

Geriatric Use: Patients over 65 and older may experience: fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, appetite disturbance, abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary Cinzia, and weight decrease. Monitor closely.

For more detailed information, please refer to the full Prescribing Information at phyrago.com/PI/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at
1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

US-DAS-2500114 | October 2025

(Press release, Cycle Pharmaceuticals, OCT 16, 2025, View Source [SID1234656699])

On October 16, 2025 Akeso Inc. (9926.HK) reported that the groundbreaking results from the registrational Phase III AK112-306/HARMONi-6 study of ivonescimab have been accepted for publication in The Lancet. The study evaluated ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, combined with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). The article of Lancet will be simultaneously published during the 2025 European Society for Medical Oncology (2025 ESMO (Free ESMO Whitepaper)) Congress.

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The HARMONi-6 trial result has been selected as a Late-Breaking Abstract (LBA) for the 2025 ESMO (Free ESMO Whitepaper) Congress. Professor Lu Shun, Director of the Oncology Department at Shanghai Chest Hospital, presented the study’s findings at the Presidential Symposium. The results of this study extend Akeso’s leadership in immunotherapy 2.0 and promise to shape future clinical strategies.

The HARMONi-6 trial marks a significant advancement for ivonescimab following its success in the head-to-head study against pembrolizumab as first-line treatment for PD-L1-positive NSCLC. This Phase III study has now demonstrated positive outcomes in a comparison of ivonescimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy for the first-line treatment of squamous NSCLC, addressing a key unmet need in the treatment for advanced squamous NSCLC using anti-angiogenic agents. These successful outcomes demonstrate that ivonescimab achieves significant clinical breakthroughs, not only in comparison to PD-1 monotherapy or PD-1 combination chemotherapy, the current standard of care for many cancers in the immuno-oncology field, but also against VEGF-targeted therapies in anti-angiogenesis.

The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC.

(Press release, Akeso Biopharma, OCT 16, 2025, View Source [SID1234656717])

On October 16, 2025 Enterome, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for follicular lymphoma in the low tumor burden "watch-and-wait" setting for its lead OncoMimics immunotherapy, EO2463. The decision highlights EO2463’s efficacy, excellent safety and tolerability as a first-in-class monotherapy in clinical testing to date in patients who currently do not normally receive any treatment as long as they do not show clinical symptoms, despite having been diagnosed with a cancer that progresses in the vast majority of cases.

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"The FDA’s decision is an important validation of the unique potential of Enterome’s OncoMimics program," said Pierre Belichard, CEO of Enterome. "It will expedite the clinical development and the regulatory pathways for EO2463, which is ready to enter registrational testing as early as next year after this Fast Track designation and a recent positive type-C meeting with the FDA."

The Fast Track designation provides increased opportunities for interaction with the FDA, rolling review and potential eligibility for priority review. EO2463 is ready for Phase 3 testing in watch-and-wait patients after showing marked efficacy as a monotherapy in interim data from the watch-and-wait population in the ongoing Phase 2 SIDNEY trial. The treatment was well tolerated, suggesting Enterome’s EO2463 immunotherapy may offer a safe and effective treatment option for patients in this setting, who have been diagnosed with a type of cancer they know is likely to progress, but show no troublesome symptoms and do not usually receive treatment.

Follicular Lymphoma (FL), one of several types of indolent Non-Hodgkin Lymphoma, is an incurable chronic condition with frequent relapses, characterized by slow progression and few symptoms, yet reduced life expectancy. It is usually diagnosed by the appearance of swollen lymph nodes, and the early stages of the disease can be characterized by a lack of troublesome symptoms such as night sweats, fever or weight loss. There is a widespread consensus among leading investigators of the need for a well-tolerated and effective monotherapy to stop or slow progression for watch-and-wait patients.

EO2463 is an innovative, off-the-shelf OncoMimics active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

OncoMimics are bacteria-derived peptide antigens that closely mimic tumor-associated antigens or lineage markers. These synthetically produced peptides are designed in silico using AI and machine learning to mine Enterome’s extensive proprietary database of 23 million commensal bacteria genes. Because these peptides are "non-self," they tap into pre-existing pools of effector-memory CD8 T cells primed by gut bacteria, enabling rapid, strong, and durable anti-tumor responses while avoiding the self-tolerance that limits many cancer immunotherapies. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

OncoMimics are easy to manufacture, store, distribute and administer as an "off-the-shelf" subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies.

(Press release, Enterome, OCT 16, 2025, View Source [SID1234656700])

On October 16, 2025 Techsomed Ltd., a pioneering medical AI-powered software company specializing in image-guided therapy reported a collaboration with Medtronic, a global leader in healthcare technology. The pilot collaboration brings together Techsomed’s BioTraceIO360 software and the Medtronic Emprint microwave ablation system as a complete solution for Image Guided Ablation Therapy. Together, Techsomed and Medtronic can support interventional radiologists (IRs) throughout the full cycle of ablation management, from planning to post-treatment assessment.

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In minimally invasive therapies such as ablation, effective image guidance is crucial. However, challenges such as limited intra-procedural visibility, non-integrated technologies, and reliance on fragmented imaging systems can hinder physicians’ ability to maintain local control of tumor margins, often leading to the need for repeat interventions.

By using Techsomed’s innovative planning, visualization, and margin confirmation software in combination with the Emprint Ablation System with Thermosphere technology, IRs will arm themselves with advanced capabilities for real-time visualization, predictive margin control, dynamic treatment planning, and scalable, spherical ablation zones, allowing them to pursue optimal treatment outcomes.

"In collaboration with Medtronic, we aim to set a new standard for minimally invasive ablation treatment—grounded in data, not assumptions," said Yossi Abu, CEO and Founder of Techsomed. "By adding our advanced imaging, real-time predictive modeling, and seamless workflow integration to the cutting-edge ablation technology offered by Medtronic and their industry-leading in-vivo therapy datasets, we aspire to bring a new level of treatment precision to our customers."

(Press release, Medtronic, OCT 16, 2025, View Source [SID1234656718])

On October 16, 2025 EORTC reported it will be prominently featured at the EANO 2025 conference, held in Prague from 16 to 19 October. Our team will present seven scientific abstracts, including two oral presentations and five posters, highlighting ongoing research in neuro-oncology.

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In addition, EORTC projects will be featured in a joint session with the Brain Tumour Group (BTG), where six participants will present on clinical trial planning and current case studies, highlighting the collaborative efforts within EORTC to advance cancer research.

Further details can be found in the table below.

EORTC ABSTRACTS
AGE AND SEX AS RISK FACTORS FOR HEALTH-RELATED QUALITY OF LIFE OUTCOMES IN GLIOMA PATIENTS: POOLED ANALYSES OF CLINICAL TRIALS FROM THE CODAGLIO 2.0 DATABASE
Ogechukwu Edeh-Asogwa, Netherlands Friday, 17 October 10:35 – 10:45
Type: Oral session
Room: Forum Hall
FINAL CLINICAL AND MOLECULAR ANALYSIS OF THE EORTC RANDOMIZED PHASE III INTERGROUP CATNON TRIAL ON CONCURRENT AND ADJUVANT TEMOZOLOMIDE IN ANAPLASTIC GLIOMA WITHOUT 1P/19Q CODELETION
Martin Van Den Bent, Netherlands Saturday, 18 October 11:25 – 11:35
Type: Oral session
Room: Forum Hall
EANO, EORTC, EPTN and ESNR consensus-based definition for post-radiotherapy MRI abnormalities in the brain: preliminary findings from an interdisciplinary Delphi study
Maarten Lambrecht, Belgium Friday, 17 October 17:00 – 18:30
Type: Poster session
Room: Forum Hall Foyer 3
VORASIDENIB AS MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMORADIOTHERAPY IN IDH-MUTANT GRADE 2 OR 3 ASTROCYTOMA: STUDY PROTOCOL FOR THE PLACEBO-CONTROLLED, TRIPLE-BLIND, RANDOMIZED PHASE III STUDY EORTC-2427 (VIGOR)
Marjolein Geurts, Netherlands Friday, 17 October 18:00 – 19:30
Type: Poster session
Room: Forum Hall Foyer 3
MGMT METHYLATION DURING THE PROGRESSION OF GLIOBLASTOMA
Bo Deng, Netherlands Saturday, 18 October 17:00 – 18:30
Type: Poster session
Room: Forum Hall Foyer 3
THE USE OF EORTC QLQ-C30 SUMMARY SCORE IN CANCER CLINICAL TRIALS AND ITS PERFORMANCE AS COMPARED WITH THE GLOBAL HEALTH / QUALITY OF LIFE SCALE: A COMPARATIVE ANALYSIS OF EFFECT SIZES
Josien Scheepens, Netherlands Saturday, 18 October 17:00-18:30
Type: Poster session
Room: Forum Hall Foyer 3
ASSOCIATION BETWEEN TEMOZOLOMIDE-RELATED HEMATOLOGICAL TOXICITY AND HRQOL SCORES IN GLIOBLASTOMA: A POOLED ANALYSIS OF THREE RANDOMIZED TRIALS
Clemens Seidel, Deutschland Sunday, 19 October 2025 12:00-12:45
Type: Poster session
Room: Forum Hall Foyer 3
SESSIONS
WHAT CAN A SUPPORTING AGENCY SUCH AS EORTC DO FOR YOU?
Michael Weller, Switzerland JOINT SESSION
Saturday, 18 October 08:00 – 08:14
South Hall 2
CLINICAL TRIAL MANAGEMENT: STEERING COMMITTEE, THE MEDICAL MONITOR AND THE DATA MONITORING COMMITTEE
Patrick Roth, Switzerland JOINT SESSION
Saturday, 18 October 08:14 – 08:28
South Hall 2
EORTC-2227 (LEGATO): LOMUSTINE WITH AND WITHOUT REIRRADIATION FOR FIRST PROGRESSION OF GLIOBLASTOMA: A RANDOMIZED PHASE III STUDY
Tomas Kazda, Czech Republic JOINT SESSION
Saturday, 18 October 08:28 – 08:36
South Hall 2
EORTC-2334 (LUMEN-1): 177LU-DOTATATE FOR RECURRENT MENINGIOMA: A RANDOMIZED PHASE II STUDY
Emeline Tabouret, France JOINT SESSION
Saturday, 18 October 08:36 – 08:44
South Hall 2
EORTC 2427 (VIGOR): VORASIDENIB AS MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMORADIOTHERAPY IN IDH-MUTANT GRADE 2 OR 3 ASTROCYTOMA: A PLACEBO-CONTROLLED RANDOMIZED PHASE III STUDY
Marta Padovan, Italy JOINT SESSION
Saturday, 18 October 08:44 – 08:52
South Hall 2
EORTC-2013 (GLIO-RARE): OBSERVATIONAL STUDY FOR ASSESSING TREATMENT AND OUTCOME OF PATIENTS WITH PRIMARY BRAIN TUMOURS DIAGNOSED ACCORDING TO CIMPACT-NOW RECOMMENDATIONS AND THE 2021 WHO CLASSIFICATION
Maximilian Mair, Austria JOINT SESSION
Saturday, 18 October 08:52 – 09:00
South Hall 2

(Press release, EORTC, OCT 16, 2025, View Source [SID1234656701])