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FDA Questions Pfizer's Approach to Expand Talzenna's Indication in Prostate Cancer

OncologyPrecision MedicineTargeted Therapy
  • The FDA has raised concerns about Pfizer's strategy to expand Talzenna's indication to all castration-resistant prostate cancer patients, questioning the reliance on an "incompletely defined" subgroup without HRR gene mutations.
  • Pfizer is seeking to broaden Talzenna's current first-line indication from only HRR-mutated castration-resistant prostate cancer to an all-comers population, representing a significant potential market expansion.
  • The regulatory scrutiny highlights ongoing challenges in precision medicine approaches and biomarker-based treatment strategies in oncology drug development.

FDA Advisory Committee Rejects Pfizer's Talzenna Expansion for Broader Prostate Cancer Population

OncologyPrecision MedicineTargeted Therapy
  • Pfizer's application to expand Talzenna's indication to all castration-resistant prostate cancer (CRPC) patients was rejected by FDA's advisory committee due to insufficient data in biomarker-negative patients.
  • The company sought to broaden Talzenna's current approval beyond patients with HRR gene mutations, but FDA questioned the reliance on an "incompletely defined" subgroup analysis.
  • FDA oncology chief Richard Pazdur emphasized that chance effects could not be ruled out due to the lack of a formal efficacy analysis in patients without HRR mutations.

Gustave Roussy Launches UMBRELLA Trial: Using Blood-Based Tumor DNA to Revolutionize Cancer Follow-Up Care

OncologyPrecision MedicineAI
  • Gustave Roussy has initiated UMBRELLA, a groundbreaking phase III trial that personalizes post-treatment cancer monitoring based on minimal residual disease (MRD) detected through blood-based circulating tumor DNA analysis.
  • The trial will evaluate two strategies: pre-emptive immunotherapy (tislelizumab) for MRD-positive patients and reduced follow-up schedules for MRD-negative patients with non-metastatic lung, colorectal, pancreatic, and soft tissue sarcomas.
  • UMBRELLA represents the first French multi-cancer trial using MRD status for therapeutic stratification, aiming to enroll over 700 patients across 10-11 centers in a collaborative effort involving Veracyte, IntegraGen, and BeiGene.

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

NCT06332274RecruitingPhase 3
Gustave Roussy, Cancer Campus, Grand Paris
Posted 4/16/2025

SISCAPA and Biognosys Partner to Advance Protein Biomarker Analysis for Clinical Trials

Precision Medicine
  • SISCAPA Assay Technologies and Biognosys have formed an exclusive strategic collaboration to provide end-to-end high-sensitivity protein analysis solutions for biopharma customers from discovery to clinical implementation.
  • The partnership combines Biognosys' TrueDiscovery and TrueSignature platforms with SISCAPA's antibody-based mass spectrometry technology to achieve unprecedented sensitivity and specificity for biomarker monitoring.
  • Biopharma companies will benefit from accelerated assay development, enhanced sensitivity for low-abundance biomarkers, and streamlined workflows for translational research and clinical trial applications.

Olaris Secures Strategic Investment from Bruker to Advance Metabolomics Diagnostic Platform

Precision Medicine
  • Framingham-based Olaris has received a strategic investment from Bruker Corporation to accelerate development of its metabolomics platform that uses machine learning for disease diagnosis and treatment optimization.
  • The partnership leverages Bruker's NMR expertise to expand Olaris' diagnostic products, including their recently launched myOLARIS-KTdx test for non-invasive kidney transplant monitoring.
  • This Series B-1 funding will enable Olaris to expand commercial partnerships and advance its diagnostic pipeline, highlighting growing industry recognition of metabolomics-based panels in precision medicine.

Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities

Drug DiscoveryPrecision MedicineDrug Discovery
  • Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform.
  • The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business.
  • Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.

FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm

Drug ApprovalOncologyRare DiseaseAIReal World EvidencePrecision Medicine
  • The FDA approved 18 new personalized medicines in 2024, representing 38% of all newly approved therapeutic molecular entities across multiple treatment areas including cancer and Alzheimer's disease.
  • Six new gene and cell-based therapies for rare genetic diseases and cancers were authorized, alongside expanded indications for 11 diagnostic testing systems and the first-ever expanded indication for an approved gene therapy.
  • Personalized medicines now constitute at least 25% of drug approvals for the past decade, a substantial increase from less than 10% ten years ago, demonstrating the healthcare system's shift away from one-size-fits-all approaches.

AI in Oncology: Transforming Community Practice from Patient Care to Revenue Cycles

AIOncologyPrecision Medicine
  • AI adoption in oncology practices is rapidly growing, with current utilization at 40-50% and projected to reach 70-80% in the next few years, enhancing both clinical decision support and practice operations.
  • AI technologies are improving patient care by facilitating education, reducing financial toxicity, streamlining practice connections, and helping clinicians manage the increasing complexity of precision medicine data.
  • Community oncology practices need a pragmatic, strategic approach to AI implementation that prioritizes specific practice needs, workflow integration, and patient readiness to maximize benefits while addressing potential disparities.

Landmark VA Study Reveals Genomic Differences in Metastatic Prostate Cancer Across Racial Groups

OncologyPrecision Medicine
  • Researchers from Moffitt Cancer Center and partners analyzed genomic data from over 5,000 veterans with metastatic prostate cancer, finding significant biological differences between non-Hispanic Black and white patients.
  • Non-Hispanic Black veterans showed higher rates of genomic alterations associated with immunotherapy benefit, while white veterans had more frequent mutations in DNA repair genes and androgen receptor pathways.
  • Despite these biological differences, both groups demonstrated similar survival outcomes when given equal access to care, highlighting the potential of precision oncology to reduce healthcare disparities.

Resistance Mechanisms Drive Personalized Treatment Selection After Osimertinib Failure in EGFR-Mutant NSCLC

Precision MedicineDrug Approval
  • Understanding specific resistance mechanisms to osimertinib is crucial for selecting optimal second-line therapies in EGFR-mutant non-small cell lung cancer patients.
  • MET amplification remains the most common resistance driver, with savolitinib plus osimertinib showing significant progression-free survival benefits in phase 2 and 3 trials.
  • Antibody-drug conjugates like datopotamab deruxtecan have demonstrated robust efficacy and received FDA accelerated approval for previously treated EGFR-mutant NSCLC.
  • The ORCHARD trial represents a precision medicine approach, assigning patients to targeted combination therapies based on their specific resistance biomarkers.

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

NCT04484142Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/30/2021

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

NCT05015608Active, Not RecruitingPhase 3
Hutchison Medipharma Limited
Posted 11/22/2021

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

NCT05338970Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 7/8/2022

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

NCT03944772Active, Not RecruitingPhase 2
AstraZeneca
Posted 6/25/2019

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

NCT04656652Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/21/2020

A trial to learn how well osimertinib with savolitinib works in people with non-small cell lung cancer (NSCLC) that has gotten worse after initial treatment with osimertinib.

2024-512581-34-00Active, Not RecruitingPhase 2
AstraZeneca AB

HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

NCT04676477Active, Not RecruitingPhase 1
Daiichi Sankyo
Posted 6/11/2021

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