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FDA's Accelerated Approval Program Shows Strong Performance Despite Recent Criticisms, Analysis Reveals

Drug ApprovalOncology
  • A comprehensive 30-year analysis of FDA's accelerated approval program demonstrates that 50% of accelerated approvals have been successfully converted to traditional approval in a median time of 3.2 years, indicating the pathway's effectiveness in providing early access to life-saving treatments.
  • The program has evolved significantly over three decades, with 83% of accelerated approvals in the last decade (2012-2021) being for oncology indications, reflecting advances in targeted therapies and established surrogate endpoints in cancer treatment.
  • While concerns exist about delayed confirmatory trials, only 12% of accelerated approvals have been withdrawn over the program's history, with FDA demonstrating improved oversight by reducing median withdrawal time from 10.4 years in the 1990s to 3.5 years in the most recent decade.
  • Government analysis reveals that Medicare and Medicaid spent over $18 billion from 2018-2021 on drugs with incomplete confirmatory trials past their original completion dates, highlighting the financial implications of program oversight challenges.

Lead Pharma and Oxeltis Secure €800K Grant to Develop First-in-Class DLBCL Therapy

OncologyDrug Discovery
  • Lead Pharma and Oxeltis received an €800K EUREKA Eurostars grant to fund their three-year EPIGENEXT project developing a first-in-class small molecule therapy for diffuse large B-cell lymphoma.
  • DLBCL affects approximately 115,000 people worldwide annually, with 30-50% of patients experiencing relapse after standard R-CHOP treatment and poor long-term survival rates.
  • The collaboration aims to address the significant unmet medical need in DLBCL treatment, where current chemotherapy approaches cause debilitating side effects and fail to cure nearly half of patients.

Cullinan Oncology and Taiho Pharmaceutical Forge $275M Strategic Collaboration for EGFR Inhibitor CLN-081/TAS6417

Targeted TherapyOncologyPrecision Medicine
  • Taiho Pharmaceutical will acquire Cullinan Pearl for $275 million upfront plus up to $130 million in regulatory milestones, gaining exclusive global rights to CLN-081/TAS6417 outside the U.S.
  • CLN-081/TAS6417 is an oral, irreversible EGFR inhibitor targeting exon 20 insertion mutations in non-small cell lung cancer, which affect approximately 2-3% of NSCLC patients globally.
  • The companies will jointly develop and co-commercialize the drug in the U.S. with equal profit sharing, while Taiho will commercialize in territories outside the U.S. and China.

HUTCHMED to Present Key Clinical Data for Multiple Cancer Therapies at ASCO 2025

Targeted TherapyOncology
  • HUTCHMED will showcase new data from several studies at the 2025 ASCO Annual Meeting, including promising results from the SACHI Phase III trial of savolitinib plus osimertinib in EGFR-mutant NSCLC with MET amplification.
  • The Phase I study of ranosidenib (HMPL-306), a dual IDH1/2 inhibitor, demonstrated favorable tolerability and 100% disease control rate in lower-grade glioma patients, showing potential for this novel targeted therapy.
  • Fruquintinib combination therapy showed clinically meaningful responses in advanced endometrial cancer patients with pMMR status, with an objective response rate of 37% in serous carcinoma subgroup and durable efficacy regardless of prior chemotherapy exposure.

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

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

AZD9291 in Combination With Ascending Doses of Novel Therapeutics

NCT02143466Active, Not RecruitingPhase 1
AstraZeneca
Posted 8/5/2014

Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

NCT05009836Active, Not RecruitingPhase 3
Hutchison Medipharma Limited
Posted 9/6/2021

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

NCT05261399RecruitingPhase 3
AstraZeneca
Posted 8/3/2022

Zanidatamab Plus Chemotherapy Shows Promising Results in Heavily Pretreated HER2-Positive Breast Cancer

Oncology
  • Zanidatamab, a novel HER2-targeted bispecific antibody, demonstrated a 36.4% objective response rate and 86.4% disease control rate when combined with chemotherapy in heavily pretreated HER2-positive breast cancer patients.
  • The combination therapy showed a median progression-free survival of 7.3 months, with 42% of patients still on treatment at data cutoff, offering new hope for patients who have progressed after multiple HER2-targeted therapies.
  • The treatment was well-tolerated with manageable side effects, primarily low-grade diarrhea, supporting further investigation as a potential new therapeutic option for advanced HER2-positive breast cancer.

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123CompletedPhase 1
Jazz Pharmaceuticals
Posted 9/30/2016

Lorlatinib Shows Promising Efficacy in ALK-Rearranged NSCLC with 21.8 Month Median PFS

Real World EvidenceOncologyTargeted Therapy
  • A real-world study of lorlatinib in ALK-rearranged non-small cell lung cancer demonstrated a median progression-free survival of 21.8 months, significantly higher than in previous trials.
  • The objective response rate was 43% with disease control achieved in 94% of patients, while 81% of patients with brain metastases showed objective response for intracranial lesions.
  • Patients experiencing adverse events, particularly hypercholesterolemia and edema, had significantly better outcomes than those without side effects, suggesting a potential correlation between drug exposure and efficacy.

Rakuten Medical Acquires Critical IRDye 700DX Assets from LI-COR to Secure Photoimmunotherapy Supply Chain

Drug ApprovalOncology
  • Rakuten Medical acquired phthalocyanine dyes including IRDye 700DX from LI-COR Biosciences to ensure consistent supply for its Illuminox cancer therapy platform.
  • The acquisition supports ongoing ASP-1929 clinical trials across multiple oncology indications and strengthens the company's photoimmunotherapy development capabilities.
  • ASP-1929 has already received conditional marketing approval in Japan for head and neck cancer and is currently being studied in a global Phase 3 trial.
  • The strategic move follows recent clinical milestones including first patient enrollment in a Phase 1b/2 combination trial with anti-PD1 therapy at MD Anderson Cancer Center.

An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

NCT04305795Active, Not RecruitingPhase 1
Rakuten Medical, Inc.
Posted 12/21/2020

Prestige Biopharma Partners with Teva Israel for Trastuzumab Biosimilar Commercialization

Monoclonal AntibodyOncology
  • Prestige Biopharma has entered an exclusive commercialization agreement with Teva Israel for its trastuzumab biosimilar Tuznue (HD201) targeting HER2-positive breast cancer and gastric adenocarcinoma.
  • Phase 3 TROIKA trial data demonstrated equivalent efficacy to Herceptin with 46.6% complete response rate in the biosimilar arm versus 46.2% for the reference product.
  • The European Medicines Agency is currently reviewing the marketing authorization application for Tuznue based on positive clinical trial results.
  • This partnership expands Prestige's global commercialization strategy, following previous agreements with Pharmapark for Russia and Mundipharma for multiple European markets.

FDA Approves Monjuvi in Combination with Lenalidomide for Relapsed/Refractory DLBCL

Drug ApprovalMonoclonal AntibodyOncology
  • The FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide as the first second-line treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
  • The approval was based on the Phase 2 L-MIND study, which demonstrated a 55% overall response rate with a 37% complete response rate and median duration of response of 21.7 months.
  • Approximately 10,000 patients are diagnosed annually in the United States with relapsed or refractory DLBCL who are not eligible for stem cell transplant, representing a significant unmet medical need.
  • Monjuvi is a humanized CD19-targeting monoclonal antibody that received accelerated approval and will be co-commercialized by MorphoSys and Incyte in the United States.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Pertuzumab Regimen Shows Modest Survival Benefit in HER2-Positive Early Breast Cancer

Monoclonal AntibodyOncologyDrug ApprovalTargeted Therapy
• The APHINITY trial's 6-year analysis reveals that adjuvant pertuzumab with trastuzumab plus chemotherapy improved overall survival by 0.9% in HER2-positive early breast cancer patients, though not reaching statistical significance.
• Patients with node-positive disease showed the most significant benefit from the pertuzumab regimen, with a 4.5% absolute improvement in invasive disease-free survival at 6 years compared to placebo.
• The pertuzumab combination maintained a favorable cardiac safety profile with severe cardiac events occurring in less than 1% of patients, supporting its continued use in high-risk HER2-positive early breast cancer.

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