Ancestim
Also known as: Ancestim, PEG‑F, pegfilgrastim, r-metHuSCF, recombinant human stem cell factor, SCF, Stemgen
Source Ancestim at Peptiology
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Summary
Ancestim is a recombinant human stem‑cell factor (rhSCF) used to enhance the collection of hematopoietic stem and progenitor cells for autologous transplantation. It is typically combined with granulocyte‑colony stimulating factor (filgrastim) and, when needed, chemotherapy, to improve the yield of CD34⁺ cells in patients whose stem‑cell mobilization is suboptimal.
Mechanism of Action
Stem‑cell factor binds the c‑kit (CD117) receptor on early hematopoietic stem and progenitor cells, activating intracellular signaling pathways that promote proliferation, survival and release of these cells from the bone‑marrow niche into peripheral blood. When given with G‑CSF, the synergistic signaling amplifies mobilization of CD34⁺ cells and may support recovery of marrow after intensive chemotherapy.
What the Research Shows
Clinical evidence shows that adding Ancestim to cyclophosphamide‑filgrastim regimens increases CD34⁺ yields (12.4 × 10⁶ vs 8.3 × 10⁶ cells/kg in a randomized trial). Observational series in multiple myeloma reported >96 % of patients achieving target yields, with optimal leukapheresis around day 11. In patients who failed prior filgrastim‑only mobilization, Ancestim rescued stem‑cell collection in roughly half of cases. A phase‑II pilot in lymphoma patients found comparable toxicity but lower mobilization success than chemotherapy‑filgrastim alone. A case report suggested rapid hematologic recovery when Ancestim was combined with filgrastim and epoetin after high‑dose chemotherapy. Systematic review of randomized trials concluded that Ancestim provides an adequate mobilization option, though some strategies achieving higher CD34⁺ yields may increase toxicity.
Reported Benefits
Ancestim can increase the number of circulating CD34⁺ cells, facilitating successful autologous graft collection, especially in patients at risk of poor mobilization or after a failed filgrastim‑only attempt. It may also aid bone‑marrow recovery in refractory failure or prolonged non‑engraftment, as suggested by case‑series observations.
Limitations of the Evidence
Evidence is largely confined to small randomized or observational studies in specific cancers (multiple myeloma, lymphoma, hematologic malignancies). Some trials showed lower success rates compared with chemotherapy‑filgrastim alone, and no large phase‑III trials have confirmed superiority. The optimal dosing schedule and patient selection criteria remain uncertain.
Safety Considerations
Adverse events were common, with 94 % of participants reporting at least one event in a phase‑II trial; serious events occurred in both study arms. Reported toxicities included neutropenia and thrombocytopenia, particularly when combined with chemotherapy. No unique severe safety signals specific to Ancestim emerged, but the overall safety profile appears comparable to other mobilization regimens.
How It Is Administered
Ancestim is administered by subcutaneous injection, often at 20 µg/kg daily, beginning after chemotherapy (typically day 1) and continued alongside filgrastim for several days. The regimen is used in mobilization protocols preceding peripheral‑blood stem‑cell collection.
Routes of Administration
Goals & Uses
- Prevention of chemotherapy‑induced neutropeniaOncology Supportive CareHigh
- Peripheral blood progenitor cell (PBPC) mobilizationHematopoieticHigh
- Facilitation of dose‑dense chemotherapy regimensOncology Supportive CareModerate
- Rescue mobilization in patients failing G-CSF aloneHematopoieticModerate
- Augmentation of CD34+ cell yields for autologous transplantOncology/TransplantationHigh
Contraindications
- Asthma or reactive airway diseasePulmonaryHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Severe renal impairment (creatinine clearance <30 mL/min) without dose adjustment dataRenalModerate
- Known hypersensitivity to pegfilgrastim, filgrastim, or any excipientAllergyHigh
- History of severe allergic or anaphylactic reactions to ancestim or related compoundsHypersensitivityHigh
- Active systemic mastocytosisHematologicHigh
Adverse Effects
- Bone painMusculoskeletalCommon
- Injection site reactionsLocalCommon
- Urticaria / generalized pruritusDermatologicCommon
- FlushingVascularCommonWarmth and redness of the skin
- Injection‑site reactionsLocalCommon
- FeverSystemicUncommonElevated body temperature
- SplenomegalyHematologicUncommon
- Systemic allergic/anaphylactic reactionsImmunologicUncommon
Drug Interactions
- Myelosuppressive chemotherapy agentsLow
- Filgrastim (G-CSF)Low
- CorticosteroidsLow
- Antihistamines (H1 blockers)Low
- Concurrent corticosteroidsModerate
Population Constraints
- Patients with prior severe allergic reactions to SCFImmunologicAbsolute
- Pediatric patientsAgeRelative
- Patients with asthma or reactive airway diseasePulmonaryAbsolute
- Pregnant or breastfeeding womenReproductiveRelative
- Pediatric patients <2 years of ageAgeRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: Prevention of chemotherapy‑induced neutropeniaEMA approval 2015; same indication as US.
- United StatesApprovedApproved: Reduction of incidence of infection in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapyFDA approval 2015 as a biosimilar to Neulasta.
- United KingdomUnapprovedNot licensed in the UK; may have been available under named patient programs historically.
US FDA‑approved biosimilar to Neulasta (pegfilgrastim) in 2015; also approved in the EU and other jurisdictions for chemotherapy‑induced neutropenia.
Evidence & Sources
- Journal ArticleModerateHerbert KE, et al.2010-01-01T00:00:00.000000Z
- Journal ArticleHighSheppard D, et al.2012-01-01T00:00:00.000000Z
- Journal ArticleUngradedBlaise D, et al.2000-01-01T00:00:00.000000Z
- Journal ArticleModerateChin-Yee IH, et al.2002-01-01T00:00:00.000000Z
- Journal ArticleModerateTo LB, et al.2003-01-01T00:00:00.000000Z
- Journal ArticleModerateJohnsen HE, et al.2011-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of patients might benefit from Ancestim?
Patients undergoing autologous stem‑cell transplantation who are predicted to mobilize poorly—such as those with prior failed filgrastim mobilization, high‑risk disease, or extensive prior therapy—may receive Ancestim to improve CD34⁺ yields.
How does Ancestim differ from using filgrastim alone?
Ancestim targets the c‑kit receptor, providing a complementary signal to G‑CSF. Clinical studies show that combining Ancestim with filgrastim (and often cyclophosphamide) yields higher CD34⁺ cell counts than filgrastim alone, though the benefit varies by regimen.
Are there any specific safety concerns with Ancestim?
The drug is generally well tolerated, but adverse events such as fever, bone‑pain, neutropenia, and thrombocytopenia have been reported, especially when used with chemotherapy. Serious events have occurred but are not unique to Ancestim.
Is Ancestim approved for stem‑cell mobilization?
Regulatory status indicates Ancestim is a prescription product, but the abstracts describe its use in clinical research and practice for mobilization; they do not specify formal regulatory approval for this indication.
What is the typical timing for stem‑cell collection after Ancestim administration?
Studies in multiple myeloma identified day 11 post‑chemotherapy as the peak peripheral CD34⁺ count, suggesting leukapheresis is most effective when scheduled around that time.
What is Ancestim used for?
Ancestim is educationally associated with: Prevention of chemotherapy‑induced neutropenia, Peripheral blood progenitor cell (PBPC) mobilization, Facilitation of dose‑dense chemotherapy regimens, Rescue mobilization in patients failing G-CSF alone, Augmentation of CD34+ cell yields for autologous transplant. Educational only — not medical advice.
How is Ancestim administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Ancestim?
Reported adverse effects include: Bone pain, Injection site reactions, Urticaria / generalized pruritus, Flushing, Injection‑site reactions, Fever, Splenomegaly, Systemic allergic/anaphylactic reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Ancestim?
Recorded contraindications: Asthma or reactive airway disease, Pregnancy, Severe renal impairment (creatinine clearance <30 mL/min) without dose adjustment data, Known hypersensitivity to pegfilgrastim, filgrastim, or any excipient, History of severe allergic or anaphylactic reactions to ancestim or related compounds, Active systemic mastocytosis. Consult a qualified clinician before use.