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Swissmedic Approves 46 New Active Substances in 2024, Marking 12% Increase in Drug Authorizations

Drug Approval
  • Swissmedic authorized 46 human medicinal products with new active substances for the Swiss market in 2024, representing a 12% increase compared to 41 approvals in 2023.
  • The Swiss regulatory agency utilized various authorization procedures including reliance procedures, fast-track processes, and international frameworks under Access and Orbis programs.
  • Swissmedic is participating in two international benchmarking studies to analyze authorization times with leading partner authorities, with findings expected to be published in 2025.
  • The agency's approval activity has shown consistent growth following the pandemic period when COVID-19 applications were prioritized over other innovative drug submissions.

Nuance Pharma's Ohtuvayre Receives First Approval Outside US for COPD Treatment in Macau

Drug Approval
• Ohtuvayre (ensifentrine), a first-in-class dual PDE3/PDE4 inhibitor, has received regulatory approval in Macau SAR for maintenance treatment of COPD in adult patients.
• The novel therapy combines bronchodilator and non-steroidal anti-inflammatory effects in a single molecule, delivered via standard jet nebulizer without requiring complex breathing coordination.
• Following its US approval in June 2024, this marks the first international regulatory clearance for Ohtuvayre, with Nuance Pharma planning NDA submission in mainland China in 2025 after completing the ENHANCE-CHINA trial.

Formycon Expands Global Reach for Eylea Biosimilar Through Strategic Partnerships with Teva and Lotus Pharmaceutical

Drug Approval
  • Teva Pharmaceuticals secured semi-exclusive commercialization rights for FYB203 (AHZANTIVE), Formycon's aflibercept biosimilar, across major European markets and Israel following FDA approval in June 2024.
  • Lotus Pharmaceutical obtained exclusive licensing rights for the same biosimilar in eight Asia-Pacific countries, expanding access to this treatment for severe retinal diseases.
  • The partnerships leverage existing commercial infrastructure and distribution networks, with Eylea achieving global sales of approximately $9 billion in 2023, including $2.9 billion in Europe.
  • European Commission approval for FYB203 was granted in January 2025, while regulatory submissions for Asia-Pacific markets are being prepared according to local requirements.

Cardiomyopathy Market Projected to Reach $20+ Billion by 2035 as Novel Therapies Advance Through Clinical Development

Drug ApprovalPrecision Medicine
  • The global cardiomyopathy market is expected to grow at a CAGR of 6.13% from 2025-2035, driven by rising cardiovascular disease prevalence and innovative therapeutic developments.
  • Cytokinetics' aficamten received FDA acceptance for its New Drug Application in December 2024, with a target action date of September 26, 2025, representing a potential breakthrough in hypertrophic cardiomyopathy treatment.
  • Novel therapeutic approaches including gene therapy, stem cell treatments, and cardiac myosin inhibitors are revolutionizing cardiomyopathy management beyond traditional beta-blockers and ACE inhibitors.
  • The United States represents the largest patient pool and market for cardiomyopathy treatments, with significant growth opportunities in precision cardiology targeting genetic causes of heart diseases.

FDA Deputy Commissioner Signals Potential Reforms to PDUFA Program

Drug Approval
  • The FDA's deputy commissioner has indicated possible significant changes to the Prescription Drug User Fee Act (PDUFA) program, which funds FDA review activities through industry fees.
  • Potential reforms may focus on streamlining the drug approval process, addressing regulatory bottlenecks, and enhancing transparency in FDA-industry interactions.
  • These changes could impact pharmaceutical companies' product development timelines and strategies as the agency seeks to balance thorough safety reviews with efficient approval pathways.

FDA Approves GSK's Nucala for COPD Treatment, Expanding Therapeutic Options

Monoclonal AntibodyDrug Approval
  • The U.S. Food and Drug Administration has approved GSK's Nucala (mepolizumab) for the treatment of chronic obstructive pulmonary disease (COPD), marking a significant advancement in respiratory care.
  • Nucala becomes the first biologic therapy approved for COPD patients with an eosinophilic phenotype, addressing an important unmet need in this difficult-to-treat population.
  • GSK is rapidly implementing launch plans for this new indication, which expands Nucala's existing approvals for severe asthma and other eosinophilic conditions.

Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy

Precision MedicineOncologyDrug ApprovalTargeted Therapy
  • Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
  • The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
  • This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.

DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer

Drug Approval
  • DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
  • The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.
  • This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

NCT06170788RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/15/2023

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

NCT06312137RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/3/2024

Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

NCT06928818Recruiting
Seoul National University Hospital
Posted 2/26/2025

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

NCT04871711CompletedPhase 3
LEO Pharma
Posted 5/10/2021

A Study of Avutometinib (VS-6766) V. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer with and Without a KRAS Mutation

NCT04625270Active, Not RecruitingPhase 2
Verastem, Inc.
Posted 12/21/2020

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers

NCT04160065Active, Not RecruitingPhase 1
TuHURA Biosciences, Inc.
Posted 3/3/2020

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

NCT02972840Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 4/5/2017

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

NCT03969004Active, Not RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 6/4/2019

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

NCT04435626CompletedPhase 3
Bayer
Posted 9/14/2020

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

NCT03742102Active, Not RecruitingPhase 1
AstraZeneca
Posted 12/21/2018

A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

NCT05980481Active, Not RecruitingPhase 2
RemeGen Co., Ltd.
Posted 8/4/2023

Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Chemotherapy in Triple Negative Breast Cancer

NCT02685059CompletedPhase 2
German Breast Group
Posted 6/1/2016

A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT06800313RecruitingPhase 1
Halda Therapeutics OpCo, Inc.
Posted 2/24/2025

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/24/2020

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

NCT05198934Active, Not RecruitingPhase 3
Amgen
Posted 4/19/2022

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

NCT06018337RecruitingPhase 3
DualityBio Inc.
Posted 1/18/2024

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

NCT05091567Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/18/2021

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

NCT04784715Active, Not RecruitingPhase 3
AstraZeneca
Posted 4/26/2021

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

NCT04622319Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/4/2020

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

NCT03401385Active, Not RecruitingPhase 1
Daiichi Sankyo Co., Ltd.
Posted 1/31/2018

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

NCT03901339CompletedPhase 3
Gilead Sciences
Posted 5/8/2019

A trial to learn how safe Dato-DXd is when given with osimertinib, and how well it works compared to osimertinib alone in people who have advanced or metastatic non-small cell lung cancer (NSCLC) with a mutation in the EGFR gene

2023-509883-89-00RecruitingPhase 3
AstraZeneca AB
Posted 4/29/2024

A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

NCT06265428Active, Not RecruitingPhase 3
DualityBio Inc.
Posted 1/29/2024

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

NCT05505916Active, Not RecruitingPhase 3
KalVista Pharmaceuticals, Ltd.
Posted 10/24/2022

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

NCT05067127CompletedPhase 3
Apellis Pharmaceuticals, Inc.
Posted 11/12/2021

Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy

NCT02940262CompletedPhase 3
Jonsson Comprehensive Cancer Center
Posted 9/15/2016

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

SKB264 Injection Vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

NCT05347134Active, Not RecruitingPhase 3
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/10/2022

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

NCT06435429RecruitingPhase 3
Jazz Pharmaceuticals
Posted 8/13/2024

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

NCT05409066Active, Not RecruitingPhase 3
Genmab
Posted 9/20/2022

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

NCT05950945RecruitingPhase 3
Daiichi Sankyo
Posted 12/30/2023

Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

NCT03049189Active, Not RecruitingPhase 3
ITM Solucin GmbH
Posted 2/2/2017

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

NCT04704934Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 5/21/2021

68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery

NCT03368547CompletedNot Applicable
Jonsson Comprehensive Cancer Center
Posted 12/12/2016

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

NCT06074588RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 11/12/2023

A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib

2024-511362-37-00Active, Not RecruitingPhase 3
AstraZeneca AB
Posted 10/4/2024

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

NCT06452277RecruitingPhase 3
Bayer
Posted 8/28/2024

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

NCT04482309RecruitingPhase 2
AstraZeneca
Posted 8/18/2020

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 6/11/2024

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

NCT05215340RecruitingPhase 3
Daiichi Sankyo
Posted 3/4/2022

Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer

NCT05912062Recruiting
Institut Català d'Oncologia
Posted 3/22/2021

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

NCT05104866Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/18/2021

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

NCT05555732RecruitingPhase 3
Daiichi Sankyo
Posted 1/11/2023

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

NCT05259917CompletedPhase 3
KalVista Pharmaceuticals, Ltd.
Posted 2/22/2022

Pembrolizumab With or Without Maintenance MK‑2870 in Metastatic Squamous NSCLC

2023-510128-66-00RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 6/10/2024

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)

NCT06100874RecruitingPhase 2
Adrienne G. Waks
Posted 11/20/2023

A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

NCT04818333Active, Not RecruitingPhase 1
Jiangsu HengRui Medicine Co., Ltd.
Posted 4/23/2021

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

NCT03425643Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/24/2018

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399RecruitingPhase 1
Syndax Pharmaceuticals
Posted 11/5/2019

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

NCT03505710TerminatedPhase 2
Daiichi Sankyo
Posted 5/21/2018

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

NCT03765918Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/17/2018

Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211RecruitingPhase 2
AstraZeneca
Posted 9/6/2022

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

NCT05099172Active, Not RecruitingPhase 1
Bayer
Posted 10/25/2021

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

NCT05351788RecruitingPhase 2
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 5/20/2022

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

NCT05257408Active, Not RecruitingPhase 3
Corcept Therapeutics
Posted 6/29/2022

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

IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

NCT03902184Active, Not RecruitingPhase 2
Innate Pharma
Posted 5/22/2019

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

NCT03529110Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 8/9/2018

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

NCT05113251Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/25/2021

Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

NCT05425940Active, Not RecruitingPhase 3
Exelixis
Posted 9/7/2022

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839Active, Not RecruitingPhase 2
Celgene
Posted 7/14/2020

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

NCT02918357CompletedPhase 2
University of California, San Francisco
Posted 9/15/2016

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

NCT04014075CompletedPhase 2
Daiichi Sankyo
Posted 11/26/2019

A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06944496Not Yet RecruitingPhase 3
RemeGen Co., Ltd.
Posted 5/15/2025

Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

NCT04989816CompletedPhase 2
AstraZeneca
Posted 8/20/2021

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

NCT04592913Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/17/2020

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

NCT03615326Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 10/5/2018

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

NCT04067336RecruitingPhase 1
Kura Oncology, Inc.
Posted 9/12/2019

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

"Study of chemotherapy vs immunotherapy for patients with lung cancer bounded in the thorax and completely resected"

2024-513730-38-00Active, Not RecruitingPhase 3
Fundacion GECP

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

NCT06112379Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/14/2023

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

NCT05840211Active, Not RecruitingPhase 3
Gilead Sciences
Posted 5/8/2023

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT05243550Active, Not RecruitingPhase 3
UroGen Pharma Ltd.
Posted 3/1/2022

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

NCT05687266Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/29/2022

Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

NCT02919111CompletedPhase 2
University of California, San Francisco
Posted 9/23/2016

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 9/1/2015

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer

NCT04744831CompletedPhase 2
Daiichi Sankyo
Posted 3/5/2021

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

NCT04395677Active, Not RecruitingPhase 2
AnHeart Therapeutics Inc.
Posted 7/7/2020

A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma

NCT05972720TerminatedPhase 2
CARGO Therapeutics
Posted 8/1/2023

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

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

NCT04266249Active, Not RecruitingPhase 2
ECOG-ACRIN Cancer Research Group
Posted 3/13/2020

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04612751Active, Not RecruitingPhase 1
AstraZeneca
Posted 2/2/2021

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 2/23/2021

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

NCT04919811Active, Not RecruitingPhase 2
Nuvation Bio Inc.
Posted 9/1/2021

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

NCT06179069RecruitingPhase 1
Zai Lab (Shanghai) Co., Ltd.
Posted 1/23/2024

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

NCT03329690CompletedPhase 2
Daiichi Sankyo Co., Ltd.
Posted 11/2/2017

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

NCT04872101CompletedPhase 3
LEO Pharma
Posted 5/25/2021

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

NCT03767348RecruitingPhase 2
Replimune Inc.
Posted 9/20/2017

Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms

Monoclonal AntibodyDrug Approval
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo.
• The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo.
• Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

FDA Considers Revoking Pfizer COVID-19 Vaccine Authorization for Healthy Children Under 5

Drug Approval
  • The FDA is weighing whether to revoke Pfizer's emergency use authorization for its COVID-19 vaccine in healthy children aged 6 months to 4 years, potentially limiting vaccination options for parents ahead of the 2025-2026 respiratory virus season.
  • Moderna's COVID-19 vaccine received full FDA approval in July for children 6 months to 11 years old, but only for those at increased risk of severe COVID-19, leaving healthy young children without official vaccination options if Pfizer's authorization is withdrawn.
  • The potential revocation follows policy changes under HHS Secretary Robert F. Kennedy Jr., who removed COVID-19 vaccines for healthy children from the CDC's immunization schedule in May 2025, citing lack of evidence that healthy kids need vaccination.
  • Pediatric advocates warn that losing Pfizer's authorization would create significant access barriers, forcing parents to drive hours for vaccines and potentially requiring off-label use of Moderna's vaccine without insurance coverage guarantees.

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