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Also known as Pegfilgrastim
MYL-1401H · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| MYL-1401H | EXPERIMENTAL | MYL-1401H |
| Neulasta | ACTIVE_COMPARATOR | Neulasta |
| Name | Type | Description |
|---|---|---|
| MYL-1401H | BIOLOGICAL | During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy. |
| Neulasta | BIOLOGICAL | During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy. |
Inclusion Criteria: * Signed and dated written informed consent. * Patients ≥18 years. * Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug. * Newly ...
MYL-1401H is being developed for use in breast neoplasms, specifically to manage chemotherapy-induced febrile neutropenia in patients receiving myelosuppressive chemotherapy for breast cancer. It is a monoclonal antibody studied as a supportive care treatment in this oncology setting.
MYL-1401H is being developed by Viatris Inc., which trades on the Nasdaq under the ticker symbol VTRS. Viatris is the sponsor of the clinical program for this monoclonal antibody candidate.
MYL-1401H is in Phase 3 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 3 program includes one completed trial, and no active trials are currently listed.
MYL-1401H has been studied in the Phase 3 trial NCT02467868, titled "Efficacy and Safety Study With MYL-1401H and Neulasta." This completed trial enrolled 193 participants with breast neoplasms and chemotherapy-induced febrile neutropenia across Bulgaria, Georgia, Germany, Hungary, Poland, and Ukraine.
The Phase 3 trial NCT02467868 was a randomized, double-blind, active-controlled study. It enrolled 193 participants aged 18 years and older, with no biomarker selection, and compared MYL-1401H with Neulasta in patients with breast neoplasms and chemotherapy-induced febrile neutropenia.