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Servier India Launches First-in-Class IDH1-Targeted Therapy Ivosidenib for Rare Blood and Bile Duct Cancers

Targeted TherapyDrug ApprovalOncologyRare DiseasePrecision Medicine
  • Servier India received CDSCO approval on May 14, 2025, to launch Ivosidenib (Tibsovo®), the first oral targeted therapy for IDH1-mutated acute myeloid leukemia and cholangiocarcinoma in India.
  • The therapy addresses a critical unmet medical need, as only 30-40% of AML patients in India receive adequate treatment and IDH1 mutations occur in approximately 7-14% of Indian AML patients.
  • Ivosidenib has already gained regulatory approval in over 42 countries, including FDA approval in 2019 and EMA approval in 2023 for specific patient populations.
  • The company is prioritizing accessibility and affordability through collaborations with healthcare providers, patient advocacy groups, and policymakers to ensure broader patient access across India.

Clarity Pharmaceuticals' 64Cu-SARTATE Shows Superior Lesion Detection in Phase II DISCO Trial for Neuroendocrine Tumors

Oncology
  • Clarity Pharmaceuticals' Phase II DISCO trial demonstrated that 64Cu-SARTATE detected 393-488 lesions compared to 186-265 lesions identified by standard 68Ga-DOTATATE imaging in 45 patients with neuroendocrine tumors.
  • The diagnostic imaging study confirmed 64Cu-SARTATE's safety and superior effectiveness in detecting NET lesions, substantially outperforming the current standard of care across multiple readers.
  • Clarity plans to initiate FDA discussions for a registrational Phase III study, positioning 64Cu-SARTATE as a potential best-in-class diagnostic agent that could improve clinical decision-making and treatment outcomes for NET patients.

A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)

NCT04438304CompletedPhase 2
Clarity Pharmaceuticals Ltd
Posted 3/2/2021

Dr. Reddy's and Alvotech Partner to Develop Keytruda Biosimilar in $29.5 Billion Market

Oncology
  • Dr. Reddy's Laboratories and Alvotech have entered a collaboration and license agreement to co-develop, manufacture, and commercialize a biosimilar version of Keytruda (pembrolizumab) for global markets.
  • Keytruda generated $29.5 billion in sales globally in 2024 and is indicated for the treatment of numerous cancer types including lung cancer and melanoma.
  • The partnership aims to combine both companies' biosimilar capabilities to accelerate development and expand global access to this critical immuno-oncology therapy.
  • Under the agreement, both parties will share development and manufacturing costs and responsibilities, with each having rights to commercialize the product globally subject to certain exceptions.

Acerand Therapeutics Initiates First-in-Human Trial of Novel CYP11A1 Inhibitor ACE-232 for Advanced Prostate Cancer

Oncology
  • Acerand Therapeutics has dosed the first patient in a Phase I clinical trial of ACE-232, a novel oral CYP11A1 inhibitor for metastatic castration-resistant prostate cancer.
  • The multicenter study is being conducted in both the United States and China, comprising dose-escalation and dose-optimization phases to evaluate safety and determine the recommended Phase II dose.
  • Preclinical data showed ACE-232 demonstrated superior potency, efficacy, and pharmacokinetic properties compared to other investigational CYP11A1 inhibitors, including MK-5684.
  • The drug targets CYP11A1, a key enzyme in steroid hormone biosynthesis, offering a novel therapeutic mechanism for androgen-dependent prostate cancer, including enzalutamide or abiraterone-resistant cases.

Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

NCT06801236RecruitingPhase 1
Acerand Therapeutics (Hong Kong) Limited
Posted 5/12/2025

RET Inhibitor Rechallenge Shows Promise in Pre-Treated NSCLC Patients After Toxicity-Related Discontinuation

Targeted TherapyOncology
  • Rechallenge with a different first-generation RET inhibitor after toxicity-related discontinuation achieved a 50% objective response rate and 9.89-month median progression-free survival in RET-rearranged NSCLC patients.
  • The retrospective multicenter study from the RET MAP registry demonstrated that switching to a different RET inhibitor of the same class remains effective after initial treatment discontinuation due to side effects.
  • RET inhibitor rechallenge after disease progression showed limited efficacy as monotherapy with only 18% response rate, though combination therapies targeting bypass resistance showed some promise.
  • The findings provide new evidence for treatment sequencing in RET-rearranged NSCLC, a rare subset affecting 1-2% of advanced lung cancer patients with limited therapeutic options.

TriSalus Launches Enhanced TriNav FLX Infusion System for Improved Tumor Drug Delivery

Oncology
  • TriSalus Life Sciences has launched the TriNav FLX Infusion System, featuring enhanced trackability with twice the length of flexible material at the distal end for easier navigation through tortuous vessels.
  • The new system demonstrates a 28% reduction in force during navigation compared to standard TriNav designs in benchtop models, particularly benefiting procedures requiring precise control in challenging peripheral vascular anatomy.
  • TriNav FLX is eligible for dual reimbursement coverage under HCPCS codes C8004 for simulation/mapping and C9797 for treatment procedures, allowing clinicians to use the system for both planning and delivery in radioembolization.
  • The system retains the same Pressure-Enabled Drug Delivery (PEDD) benefits as existing TriNav products while expanding treatment options for interventional radiologists treating solid tumors.

Daiichi Sankyo's New CEO Charts Course for ADC Expansion Beyond Enhertu Success

OncologyDrug Approval
  • Hiroyuki Okuzawa assumed leadership of Daiichi Sankyo two months ago, inheriting a company strengthened by three major pharmaceutical licensing deals worth up to $27 billion based on ADC technology.
  • Enhertu demonstrated potential as frontline therapy for advanced breast cancer at ASCO 2025, continuing the drug's track record of clinical success since 2022.
  • The company plans to have five ADCs approved across more than 30 tumor types by 2030, targeting treatment of nearly 400,000 cancer patients annually.
  • Okuzawa faces the challenge of identifying next-generation growth drivers while navigating development setbacks and potential trade policy impacts on global supply chains.

Vividion Secures Exclusive Rights to First-in-Class WRN Inhibitor VVD-214 for MSI-High Cancers

Precision MedicineOncology
  • Vividion Therapeutics has secured exclusive worldwide rights to develop VVD-214, the only clinical-stage covalent inhibitor of Werner helicase (WRN) currently in development globally.
  • Preliminary data from a first-in-human Phase I study presented at AACR showed VVD-214 is well tolerated with promising signs of activity in solid tumors with high microsatellite instability.
  • The compound targets a synthetic lethal pathway in MSI-high cancers including colorectal, endometrial, ovarian, and gastric tumors, addressing significant unmet medical need in patients who relapse or become refractory to immune checkpoint inhibitors.

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

NCT06004245RecruitingPhase 1
Hoffmann-La Roche
Posted 1/25/2024

Tata Memorial Centre Partners with GE HealthCare to Establish Advanced Cancer Research & Innovation Centre

AIOncology
  • Tata Memorial Centre has signed a Memorandum of Understanding with GE HealthCare Technologies Inc. to establish a Cancer Research & Innovation Centre, with TMC serving as the clinical oncology partner and GE HealthCare as the technology partner.
  • The five-year collaboration will focus on accelerating development and validation of AI-based applications for medical imaging, clinical workflows, and advanced visualization tools in oncology care.
  • The partnership addresses the urgent need for enhanced cancer care as India faces a forecasted 12.8% rise in cancer incidence by 2025, with emphasis on early detection and equitable access challenges.
  • A Joint Working Group will chart key project areas including data annotation for application development and enterprise health informatics solutions to support personalized cancer care.

Phase 3 Trial Shows Promise for Adjuvant BRAF/MEK Inhibitor Combination in High-Risk Melanoma

Targeted TherapyOncology
  • The phase 3 EORTC-2139-MG/Columbus-AD trial demonstrated that adjuvant encorafenib plus binimetinib improved 12-month recurrence-free survival to 86% versus 70% with placebo in patients with stage IIB/C BRAF V600-mutant melanoma.
  • The combination therapy was generally well tolerated with a manageable safety profile, though 33% of patients discontinued treatment due to adverse events.
  • This represents the first randomized adjuvant trial of BRAF-directed therapy in stage IIB/IIC melanoma, potentially offering patients an alternative to immunotherapy in the adjuvant setting.

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

NCT01909453CompletedPhase 3
Pfizer
Posted 9/12/2013

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

NCT05270044Active, Not RecruitingPhase 3
Pierre Fabre Medicament
Posted 5/2/2022

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