Neulapeg (pegfilgrastim biosimilar) / GC Biopharma - LARVOL DELTA

Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX (clinicaltrials.gov) - P2 | N=78 | Active, not recruiting | Sponsor: Yonsei University

Metastases • New P2 trial • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Seoul National University Hospital | Recruiting ➔ Completed | N=32 ➔ 19 | Trial completion date: Jun 2025 ➔ Dec 2022

Enrollment change • Trial completion • Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

GC Biopharma gets IND approval for neutropenia treatment Neulapeg (Korea Biomedical Review) - "GC Biopharma said Thursday it has received an investigational new drug (IND) approval from the Ministry of Food and Drug Safety for the researcher-led administration of Neulapeg on the same day after anticancer chemotherapy. The company said it is the first such clinical trial to be held in Korea....The purposes of the upcoming clinical trial include the non-inferiority evaluation of preventing neutrophil depletion by dividing 160 colorectal cancer, pancreatic cancer, and small cell lung cancer patients into two groups and administering Neulapeg on the day of anti-cancer treatment and after 24 hours."

New trial • Non-US regulatory • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Pancreatic Cancer • Small Cell Lung Cancer

Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. (PubMed, J Pediatr Hematol Oncol) - P2 | "Pegteograstim is safe and shows comparable efficacy to conventional filgrastim in children and adolescents. Randomized controlled trials are needed to confirm its safety and efficacy."

Clinical • Journal • Dermatology • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Respiratory Diseases • Solid Tumor • Urticaria

GC Pharma releases neutropenia drug injection aid [Google translation] (Korea Biomedical Review) - "GC Pharma said Monday that it has begun supplying HugPEG, an injection aid for Neulapeg (ingredient: pegteograstim), to neutropenia patients who have to administer the drug themselves."

General devices event • Neutropenia

GC Pharma confirms safety, efficacy of neutropenia drug for solid cancer (Korea Biomedical Review) - P4, N=65; “GC Pharma said Tuesday that the company has confirmed the safety and efficacy of its neutropenia therapy for solid cancer, Neulapeg (ingredient: pegteograstim), in the four-year post-market surveillance (PMS)…The drug did not induce bone pain and showed lower pain-related adverse reactions in patients over 65 than those under 65…In the PMS, 11 patients reported adverse drug reactions, but only one experienced a serious response.”

P4 data • Neutropenia • Oncology • Solid Tumor

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim. (PubMed, Cancer Med) - "The following pegylated G-CSFs were analyzed in this study: reference pegfilgrastim (Neulasta ) and two of its biosimilars (tripegfilgrastim; Dulastin and pegteograstim; Neulapeg ). The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored."

Clinical • Journal • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology