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BDR Pharmaceutical Launches First Generic Apalutamide in India for Prostate Cancer Treatment

Oncology
  • BDR Pharmaceutical has launched India's first generic version of apalutamide (brand name Apatide) for treating metastatic castration-sensitive and non-metastatic castration-resistant prostate cancer.
  • The generic drug is priced at one-third the cost of the innovator brand, with 60 tablets costing Rs 22,500 and 120 tablets costing Rs 45,000.
  • Clinical data from the SPARTAN trial showed apalutamide plus androgen-deprivation therapy reduced disease progression risk by 71% and improved median progression-free survival from 14.7 to 40.5 months.
  • The launch addresses India's growing prostate cancer burden, where it ranks as the second most common cancer and sixth leading cause of cancer deaths among men.

Roche Withdraws Tecentriq from Bladder Cancer Market Following Failed Confirmatory Trial

Oncology
  • Roche voluntarily withdrew Tecentriq (atezolizumab) from the U.S. bladder cancer market after the IMVigor130 trial failed to demonstrate statistically significant overall survival benefit.
  • The phase 3 confirmatory trial showed patients receiving Tecentriq plus chemotherapy lived a median of 16 months compared to 13.4 months with chemotherapy alone, but the difference was not statistically significant.
  • This withdrawal completes the removal of all "dangling" accelerated approvals for Tecentriq, reflecting increased FDA scrutiny of cancer immunotherapy approvals that failed confirmatory studies.
  • The decision affects treatment for locally advanced or metastatic urothelial carcinoma patients who are cisplatin-ineligible, leaving a significant unmet medical need in advanced bladder cancer.

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

NCT02807636CompletedPhase 3
Hoffmann-La Roche
Posted 6/30/2016

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

NCT02108652CompletedPhase 2
Hoffmann-La Roche
Posted 5/31/2014

Genmab and AbbVie Submit Regulatory Applications for Epcoritamab Bispecific Antibody in Relapsed/Refractory B-Cell Lymphomas

Oncology
  • Genmab submitted a Biologics License Application to the FDA for subcutaneous epcoritamab to treat relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy.
  • AbbVie's Marketing Authorization Application for epcoritamab in relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
  • The regulatory submissions are supported by results from the pivotal EPCORE NHL-1 Phase 2 trial evaluating epcoritamab's safety and efficacy in patients with CD20+ mature B-cell non-Hodgkin lymphoma.
  • Epcoritamab is an investigational bispecific antibody designed to simultaneously bind CD3 on T-cells and CD20 on B-cells, inducing T-cell mediated killing of malignant B-cells.

Photocure and Karl Storz Launch Advanced Blue Light Cystoscopy System in US Market

Oncology
  • Photocure ASA announces the commercial availability of Karl Storz's New Blue Light equipment powered by Saphira technology in the United States for bladder cancer detection.
  • The advanced system shows strong market demand with orders outpacing previous systems, signaling potential for blue light cystoscopy to become standard of care for bladder cancer visualization.
  • Bladder cancer affects 1.72 million patients globally with high recurrence rates up to 78% over five years, making improved detection technology critically important for patient outcomes.

Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance

Targeted TherapyOncologyPrecision Medicine
• Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
• MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
• The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.

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.

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

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

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

AZD9291 in Combination With Ascending Doses of Novel Therapeutics

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

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

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