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FULPHILA (PEGFILGRASTIM-JMDB)
FULPHILA (generic name: PEGFILGRASTIM-JMDB) is a Leukocyte Growth Factor [EPC] drug developed by MYLAN GMBH. It is currently FDA-approved for Allogeneic peripheral blood stem cell transplant, Chemotherapy-induced neutropenia.
FULPHILA is a granulocyte colony-stimulating factor receptor agonist, classified as an AGONIST. It is being studied in clinical trials for various conditions, including Stage I-IV Adrenal Cortical Carcinoma and B Acute Lymphoblastic Leukemia.
At a glance
| Generic name | PEGFILGRASTIM-JMDB |
|---|---|
| Sponsor | MYLAN GMBH |
| Drug class | Leukocyte Growth Factor [EPC] |
| Target | Granulocyte colony-stimulating factor receptor |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Approved indications
- Allogeneic peripheral blood stem cell transplant
- Chemotherapy-induced neutropenia
Common side effects
- Bone pain
- Pain in extremity
Serious adverse events
- Leukocytosis (WBC counts > 100 x 10^9/L)
Key clinical trials
- Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Ly (Phase 2)
- Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (Phase 2)
- Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplasti (Phase 2)
- 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)
- Ruxolitinib in Combination With Chemotherapy for Untreated Nodal T-Follicular Helper (TFH) Cell Lymphomas (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)
- Phase I/Ib Study of Parsaclisib (INCB50465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (PaR-CHOP) Immunochemotherapy for Patients With Newly Diagnosed High Risk Diffuse Lar (Phase 1)
- A Phase I Study Evaluating Copanlisib in Combination With R-GCD (Gemcitabine, Carboplatin, Dexamethasone, and Rituximab) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Risk Follicular (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FULPHILA CI brief — competitive landscape report
- FULPHILA updates RSS · CI watch RSS
- MYLAN GMBH portfolio CI
Frequently asked questions about FULPHILA
What is FULPHILA?
FULPHILA (PEGFILGRASTIM-JMDB) is a Leukocyte Growth Factor [EPC] drug developed by MYLAN GMBH, indicated for Allogeneic peripheral blood stem cell transplant, Chemotherapy-induced neutropenia.
What is FULPHILA used for?
FULPHILA is indicated for Allogeneic peripheral blood stem cell transplant, Chemotherapy-induced neutropenia.
Who makes FULPHILA?
FULPHILA is developed and marketed by MYLAN GMBH (see full MYLAN GMBH pipeline at /company/mylan-gmbh).
What is the generic name of FULPHILA?
PEGFILGRASTIM-JMDB is the generic (nonproprietary) name of FULPHILA.
What drug class is FULPHILA in?
FULPHILA belongs to the Leukocyte Growth Factor [EPC] class. See all Leukocyte Growth Factor [EPC] drugs at /class/leukocyte-growth-factor-epc.
What development phase is FULPHILA in?
FULPHILA is FDA-approved (marketed).
What are the side effects of FULPHILA?
Common side effects of FULPHILA include Bone pain, Pain in extremity. Serious adverse events: Leukocytosis (WBC counts > 100 x 10^9/L).
What does FULPHILA target?
FULPHILA targets Granulocyte colony-stimulating factor receptor and is a Leukocyte Growth Factor [EPC].
Related
- Drug class: All Leukocyte Growth Factor [EPC] drugs
- Target: All drugs targeting Granulocyte colony-stimulating factor receptor
- Manufacturer: MYLAN GMBH — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Allogeneic peripheral blood stem cell transplant
- Indication: Drugs for Chemotherapy-induced neutropenia