For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. BLA 761084, held by Kashiv Biosciences LLC. Pegfilgrastim-Pbbk.
As of Nov 13, 2026, BLA 761084 (Fylnetra), held by Kashiv Biosciences LLC, was first approved by FDA on May 26, 2022, with 1 approved supplement and 1 published complete response letter.
FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2022 | Original applicationNew active ingredient · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Aug 11, 2021 | TPI-120Microbiology, Product Quality, Center For Devices And Radiological Health | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fylnetra6MG/0.6ML · injectable;injection | Pegfilgrastim-Pbbk | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 23, 2025 | Supplement 7Biosimilar · Standard review | Approved | |
| May 26, 2022 | Original applicationNew active ingredient · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
