Last reviewed 2026-06-02 · How we verify

FYLNETRA (PEGFILGRASTIM-PBBK)

FYLNETRA (generic name: PEGFILGRASTIM-PBBK) is a Leukocyte Growth Factor [EPC] drug developed by KASHIV BIOSCIENCES LLC. It is currently FDA-approved for Decrease incidence of infection in cancer patients, Increase survival in radiation exposure.

Pegfilgrastim binds to specific cell surface receptors on hematopoietic cells, stimulating their proliferation, differentiation, and functional activation.

FYLNETRA is a drug that has been studied in clinical trials for various types of cancer, including Renal Pelvis and Ureter Urothelial Carcinoma, Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma, Embryonal Carcinoma, and Immature Teratoma. It is a granulocyte colony-stimulating factor receptor agonist, which means it works by stimulating the production of white blood cells.

At a glance

Mechanism of action

Pegfilgrastim works by binding to specific receptors on the surface of hematopoietic cells. This binding triggers the cells to multiply, differentiate, and become functionally active, which helps in the production of blood cells.

Approved indications

• Decrease incidence of infection in cancer patients
• Increase survival in radiation exposure

Common side effects

• Bone pain
• Pain in extremity

Key clinical trials

• A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage I (Phase 2)
• Open Label Randomized Two Treatment Two Sequence Two Period Crossover Single Dose Pharmacokinetic Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Prefilled Syringe With on Body Inje (Phase 1)
• Ruxolitinib in Combination With Chemotherapy for Untreated Nodal T-Follicular Helper (TFH) Cell Lymphomas (Phase 1)
• An Open Label, Randomized, Two-treatment, Two Sequence, Two Period, Crossover, Single Dose, Comparative Pharmacokinetic, Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Pre-Filled S (Phase 1)
• A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor (Phase 2)
• A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (Phase 3)
• A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas (Phase 1)
• Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adu (Phase 2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• FYLNETRA CI brief — competitive landscape report
• FYLNETRA updates RSS · CI watch RSS
• KASHIV BIOSCIENCES LLC portfolio CI

Frequently asked questions about FYLNETRA

Related

• Drug class: All Leukocyte Growth Factor [EPC] drugs
• Target: All drugs targeting specific cell surface receptors
• Manufacturer: KASHIV BIOSCIENCES LLC — full pipeline
• Therapeutic area: All drugs in Other
• Indication: Drugs for Decrease incidence of infection in cancer patients
• Indication: Drugs for Increase survival in radiation exposure

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing