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PSMA PET Imaging Transforms Prostate Cancer Management with Multiple FDA-Approved Agents

Drug ApprovalOncology
  • PSMA PET imaging has revolutionized prostate cancer detection and management, particularly in biochemical recurrence settings, with multiple FDA-approved agents now available including gallium-68 PSMA-11, piflufolastat F 18, and flotufolastat F 18.
  • The newer agent flotufolastat F 18 offers unique advantages in postprostatectomy recurrence scenarios due to its reduced bladder activity, allowing better visualization of potential recurrence in the prostate bed.
  • While PSMA PET has largely replaced fluciclovine F 18, the metabolic tracer still maintains a role in specific scenarios including tumors with low PSMA expression and neuroendocrine differentiation cases.
  • Expert panels emphasize that agent selection often depends on institutional availability and specific clinical contexts, as detection rates and sensitivity remain comparable between different PSMA PET tracers.

Protein Therapeutics Market Surges to $400 Billion as 20 New Drugs Gain Approval in 2023

Monoclonal AntibodyDrug Approval
  • The global protein therapeutics market reached an estimated $400 billion in value, driven by increasing pharmaceutical company investment in advanced protein-based drug development strategies.
  • Nearly 20 protein-based drugs received regulatory approval in 2023 for treating various diseases including cancer and metabolic disorders, demonstrating accelerated development in this therapeutic area.
  • Monoclonal antibodies dominate the protein therapeutics sector with an estimated market value of $48.5 billion by 2011, representing the largest segment ahead of insulin therapies.
  • The protein therapeutics market is projected to grow at a compound annual growth rate of approximately 13% during 2012-2014, significantly outpacing overall pharmaceutical market growth.

Long-Term Study Confirms Rivaroxaban's Safety and Efficacy for Extended Use in Children with Venous Thromboembolism

Drug Approval
  • A landmark study led by MedUni Vienna provides the first reliable evidence for extended anticoagulation with rivaroxaban in children with venous thromboembolism, showing low risks of recurrence and serious bleeding.
  • The research, published in The Lancet Haematology, builds on the 2020 EINSTEIN Jr study that led to rivaroxaban's global approval for pediatric use in 2021.
  • Rivaroxaban offers significant advantages over traditional anticoagulants for children, including oral administration and elimination of regular blood tests, establishing it as the first scientifically-proven age-appropriate alternative to standard therapies.

FDA Approves Qamzova: China-Developed Long-Acting Injectable Painkiller to Combat Opioid Crisis

Drug Approval
• Qamzova, developed by Nanjing-based Delova Biotech, has received FDA approval as the world's first long-acting injectable NSAID analgesic, providing 24-hour pain relief with a single daily injection.
• The meloxicam-based medication offers a safer alternative for moderate-to-severe pain management, potentially reducing dependency on addictive opioids like fentanyl that have fueled the US overdose epidemic.
• This approval represents a significant milestone for China's pharmaceutical industry, demonstrating the country's growing capabilities in innovative drug development and international market penetration.

European Commission Approves First MEK Inhibitor for NF1-Associated Plexiform Neurofibromas in Adults and Children

Drug ApprovalRare DiseaseOrphan Drug
  • The European Commission has granted conditional approval for Ezmekly (mirdametinib), the first therapy approved for both adults and children with neurofibromatosis type 1-associated plexiform neurofibromas.
  • The approval is based on the ReNeu Phase 2b trial results showing objective response rates of 41% in adults and 52% in children, with median tumor volume reductions of approximately 40% in both populations.
  • Ezmekly is a selective MEK 1/2 inhibitor that blocks the RAF-MEK-ERK pathway, addressing a significant unmet need for patients with symptomatic, inoperable plexiform neurofibromas aged 2 years and above.
  • The drug demonstrated a manageable safety profile with the most common adverse reactions including dermatitis acneiform, diarrhea, and elevated blood creatine phosphokinase levels.

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

NCT03962543Active, Not RecruitingPhase 2
SpringWorks Therapeutics, Inc.
Posted 9/29/2019

Amtagvi Shows Unprecedented 20% Five-Year Survival Rate in Advanced Melanoma Patients

Drug ApprovalOncology
  • Iovance Biotherapeutics has announced five-year results from the Phase 2 C-144-01 trial showing that one-time treatment with Amtagvi (lifileucel) achieved a 20% survival rate in advanced melanoma patients previously treated with checkpoint inhibitors.
  • The tumor infiltrating lymphocyte (TIL) therapy demonstrated durable responses with a 31.4% objective response rate and a median duration of response of 36.5 months, with nearly one-third of responders maintaining their responses at the five-year mark.
  • Amtagvi, which received FDA accelerated approval in February 2024, represents a significant breakthrough as the first one-time T cell therapy approved for a solid tumor cancer, offering a new option for patients with limited treatment alternatives.

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

NCT02360579CompletedPhase 2
Iovance Biotherapeutics, Inc.
Posted 9/24/2015

FDA Approves GSK's Nucala for COPD Treatment, Expanding Options for "Smoker's Lung"

Monoclonal AntibodyDrug Approval
  • The FDA has approved GSK's monoclonal antibody Nucala as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD), commonly known as "smoker's lung."
  • In late-stage clinical trials, Nucala reduced COPD exacerbations by 21% compared to placebo when combined with standard inhaled maintenance therapy over a 104-week period.
  • The approval expands treatment options for COPD, joining Sanofi/Regeneron's Dupixent and Verona Pharma's Ohtuvayre in addressing this condition that is the fourth leading cause of death worldwide.

Alteogen's Aflibercept Biosimilar Eyluxvi Receives Positive Opinion from European Medicines Agency

Drug Approval
  • Alteogen announced that its aflibercept biosimilar Eyluxvi (ALT-L9) received a positive opinion from the European Medicines Agency's CHMP committee, marking a decisive step toward European approval.
  • The positive recommendation is based on Phase 3 clinical trial results from 431 wet age-related macular degeneration patients across 12 countries, demonstrating therapeutic equivalence and safety compared to Eylea.
  • Eyluxvi targets the blockbuster ophthalmology market, with Eylea generating annual sales of $9.5 billion for treating conditions like wet age-related macular degeneration and diabetic macular edema.
  • This represents Alteogen's second biosimilar product following its Herceptin biosimilar ALT-L2, positioning the company for global pharmaceutical market expansion with expected approval by 2025.

Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD

NCT04058535CompletedPhase 1
Alteogen, Inc.
Posted 2/5/2020

Peptide Drug Conjugates Emerge as Next-Generation Cancer Therapeutics with Over 30 Candidates in Clinical Development

Targeted TherapyOncologyDrug Approval
  • Peptide drug conjugates represent a novel targeted therapy approach that combines disease-targeting peptides with small molecule drugs to deliver treatments directly to diseased tissues while minimizing systemic toxicity.
  • The global peptide drug conjugate market has experienced remarkable growth of over 300% absolute growth and 27% CAGR from 2018-2024, with market opportunities exceeding $1.4 billion.
  • Two peptide drug conjugates have received regulatory approval as of May 2025: Novartis's Lutathera for gastroenteropancreatic neuroendocrine tumors and Oncopeptides' Pepaxti for multiple myeloma.
  • More than 30 peptide drug conjugate candidates are currently advancing through various stages of clinical trials, primarily focused on oncology applications but expanding into neurodegenerative and inflammatory disorders.

FDA Approves Rejoyn, First Prescription Digital Therapeutic for Major Depressive Disorder

Drug Approval
  • Rejoyn (CT-152) became the first FDA-approved prescription digital therapeutic for major depressive disorder on March 20, 2024, marking a significant milestone in digital mental health treatment.
  • The smartphone app is indicated as adjunctive therapy for adults aged 22 and older with MDD who are already taking antidepressants, delivering six weeks of brain training exercises and therapeutic lessons.
  • In the pivotal Mirai study of 286 patients, Rejoyn demonstrated superior efficacy with an 8.78-point reduction in MADRS scores compared to 6.66 points for the control group.
  • Clinical experience shows patients find the evidence-based digital therapeutic engaging and helpful, with some requesting to repeat the program after completion.

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