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- ||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date: OASIS (CM): Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (clinicaltrials.gov) - Oct 31, 2024
P3, N=286, Recruiting, Sponsor: Amgen
Trial completion date: May 2025 --> Jan 2026
- || Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Avsola (infliximab-axxq) / Amgen
Clinical, Retrospective data, Journal: Comparison of Reference and Biosimilar Medications for Pediatric Noninfectious Uveitis. (Pubmed Central) - Oct 31, 2024
Compared with the reference infliximab, pediatric patients had fewer number of flares per year on biosimilar infliximab, but they were also on the biosimilar for a shorter duration of time compared with the reference which may confound an accurate assessment. Biosimilar infliximab had a lower cost profile compared with reference infliximab.
- | Remicade (infliximab) / J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
Journal: Inflammatory back pain as an unusual manifestation of Takayasu arteritis: a case report. (Pubmed Central) - Oct 31, 2024
Oral prednisolone was initiated at a dose of 60 mg/day with symptomatic improvement in both his inflammatory back pain and his chest pain, but he had to be switched to methotrexate and infliximab due to steroid side effects. Inflammatory aortitis should be considered as a possibility during the assessment of inflammatory back pain to mitigate the risks of delayed diagnosis.
- | Blincyto (blinatumomab) / Astellas, Amgen
Journal: Outcomes of children and young adults with B-cell acute lymphoblastic leukemia given blinatumomab as last consolidation treatment before allogeneic hematopoietic stem cell transplantation. (Pubmed Central) - Oct 31, 2024
Relapse after HSCT occurred in 16 patients, all exhibiting CD19-positive blasts; 10 of them received anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy and 2 inotuzumab as salvage therapy, leading to a 2-year post-relapse OS of 52.7%. Our results indicate that HSCT following blinatumomab in children and YA with B-ALL is highly effective, being associated with low NRM and not affecting the efficacy of subsequent salvage immunotherapies, including CAR-T cells.
- | Journal: Factors Associated with the Development of Anti-drug Antibodies to TNFi and the Consequences for Axial Spondyloarthritis: A Two-year Follow-up Study. (Pubmed Central) - Oct 31, 2024
Our results indicate that HSCT following blinatumomab in children and YA with B-ALL is highly effective, being associated with low NRM and not affecting the efficacy of subsequent salvage immunotherapies, including CAR-T cells. A total of 180 patients with axSpA (116 male, mean (
- | Ibrance (palbociclib) / Pfizer
Biomarker, Trial completion, Metastases: Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) (clinicaltrials.gov) - Oct 31, 2024
P2, N=23, Completed, Sponsor: National Cancer Institute (NCI)
A total of 180 patients with axSpA (116 male, mean ( Active, not recruiting --> Completed
- | AMG 193 / Amgen
Trial completion date: A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (clinicaltrials.gov) - Oct 31, 2024
P1/2, N=184, Recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Trial completion date: Dec 2026 --> Sep 2027
- | Journal: PCSK9 Inhibitors: The Evolving Future. (Pubmed Central) - Oct 31, 2024
Emerging treatments like Inclisiran offer long-term LDL-C control with fewer doses...PCSK9 inhibitors significantly lower LDL-C and reduce cardiovascular events, offering promising therapies for high-risk patients, including those with familial hypercholesterolemia (FH) and those who cannot tolerate statins. Future research will focus on optimizing these inhibitors, integrating complementary therapies, and exploring gene-editing technologies to improve patient outcomes.
- || NKT2152 / NiKang Therap
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: NKT2152-202: Ph2 Study NKT2152 with Palbociclib & Sasanlimab in Subjects with Advanced Clear Cell Renal Cell Carcinoma (ccRcc) (clinicaltrials.gov) - Oct 31, 2024
P2, N=172, Active, not recruiting, Sponsor: NiKang Therapeutics, Inc.
Future research will focus on optimizing these inhibitors, integrating complementary therapies, and exploring gene-editing technologies to improve patient outcomes. Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Jun 2026 | Trial primary completion date: Jun 2026 --> Jun 2025
- | Actimmune (interferon gamma-1 b) / Clinigen, Amgen
Trial primary completion date, Combination therapy: Interferon-? (IFN-?) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - Oct 31, 2024
P2, N=45, Recruiting, Sponsor: Sawa Ito, MD
Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Jun 2026 | Trial primary completion date: Jun 2026 --> Jun 2025 Trial primary completion date: Aug 2026 --> Oct 2027
- | Braftovi (encorafenib) / Pfizer
Journal: Concurrent Eruptive Melanocytic Nevi and Multiple Keratoacanthomas Induced by Encorafenib. (Pubmed Central) - Oct 31, 2024
Discontinuation of encorafenib and panitumumab led to gradual resolution of most lesions, highlighting a possible etiopathogenic link. This study emphasizes the need for thorough dermatologic evaluation and follow-up in patients receiving BRAF inhibitors to optimize management and avoid unnecessary treatment cessation.
- | Prolia (denosumab) / Amgen
Journal: Parathyroid Carcinoma Complicated by Parathyromatosis and Refractory Hypercalcemia. (Pubmed Central) - Oct 31, 2024
Despite treatment with cinacalcet and zoledronic acid, her hypercalcemia persisted until denosumab produced a dramatic response (serum calcium dropping from 16.7 to 7.9 mg/dL; PTH 1,168 pg/mL). However, she remains at risk for progressive local disease and potential distant metastases.
- || Itovebi (inavolisib) / Roche
Clinical, Journal, Metastases: Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. (Pubmed Central) - Oct 30, 2024
P2/3
The percentage of patients who discontinued any trial agent because of adverse events was low. (Funded by F. Hoffmann-La Roche; INAVO120 ClinicalTrials.gov number, NCT04191499.).
- Prolia (denosumab) / Amgen
Denosumab improves clinical benefit of PD1 inhibitors in metastatic melanoma (MM) presumably via a suppressive effect on immunoregulatory myeloid cell populations (Exhibit Halls AB - George R. Brown Convention Center) - Oct 30, 2024 - Abstract #SITC2024SITC_1919;
P2
(Funded by F. Hoffmann-La Roche; INAVO120 ClinicalTrials.gov number, NCT04191499.). We conducted a study of denosumab (D) induction followed by a combination with nivolumab (N) in PD1 inhibitor (PDi)-na
- || Ibrance (palbociclib) / Pfizer
Clinical, Journal, Real-world evidence, Real-world effectiveness, Real-world, Metastases: Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer: final results from the POLARIS trial. (Pubmed Central) - Oct 30, 2024
P
We conducted a study of denosumab (D) induction followed by a combination with nivolumab (N) in PD1 inhibitor (PDi)-na Outcomes in this large, heterogeneous, real-world population are generally consistent with previously reported results from clinical trials and other real-world studies, further supporting the use of palbociclib?+?ET in patients with HR+/HER2- ABC.
- | Lumakras (sotorasib) / Amgen
Journal: Sotorasib in KRAS p.G12C-Mutated Pulmonary Sarcomatoid Carcinoma: Therapeutic Efficacy of a KRAS Inhibitor in Symptomatic Brain Metastases. (Pubmed Central) - Oct 30, 2024
This case emphasizes the poor prognosis of patients with PSC due to a lack of therapeutic response to chemotherapy, radiation, and, as seen in this case, current targeted therapy as well. Our case emphasizes the need to further evaluate therapeutic responses of targeted therapy in this rare subtype of NSCLC.
- | Stivarga (regorafenib) / Bayer, Cabometyx (cabozantinib tablet) / Exelixis
Journal, IO biomarker: Clinical significance of upregulated Rho GTPase activating protein 12 causing resistance to tyrosine kinase inhibitors in hepatocellular carcinoma. (Pubmed Central) - Oct 30, 2024
Our case emphasizes the need to further evaluate therapeutic responses of targeted therapy in this rare subtype of NSCLC. ARHGAP12 expression is elevated in HCC and TKI-resistant HCC, and its regulatory role in FA may underlie the TKI-resistant phenotype.
- | Tavneos (avacopan) / Amgen
Journal: Avacopan in the treatment of refractory scleritis secondary to granulomatosis with polyangiitis: A case report. (Pubmed Central) - Oct 30, 2024
We report that avacopan used alongside other immunosuppressants may be a viable option in patients with GPA and concurrent refractory scleritis. Further studies are needed to establish the longer term impact of this agent on the control of scleral inflammation.
- || Keytruda (pembrolizumab) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Trial completion date, Metastases: KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study (clinicaltrials.gov) - Oct 30, 2024
P3, N=94, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Further studies are needed to establish the longer term impact of this agent on the control of scleral inflammation. Trial completion date: Nov 2025 --> Feb 2025
- | Ibrance (palbociclib) / Pfizer, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Oct 30, 2024
P2, N=47, Active, not recruiting, Sponsor: City of Hope Medical Center
Trial completion date: Nov 2025 --> Feb 2025 Recruiting --> Active, not recruiting
- ||| Keytruda (pembrolizumab) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Trial completion date, Metastases: KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov) - Oct 30, 2024
P3, N=505, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Trial completion date: Nov 2025 --> Feb 2025
- | Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / BMS
Enrollment change, Checkpoint inhibition: AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - Oct 30, 2024
P2, N=300, Suspended, Sponsor: National Cancer Institute (NCI)
Trial completion date: Nov 2025 --> Feb 2025 N=550 --> 300
- | Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
New trial: The Inflammatory Profile of Exacerbations in Patients With Severe Asthma Receiving Tezepelumab: The TezEx Study (clinicaltrials.gov) - Oct 29, 2024
P=N/A, N=150, Not yet recruiting, Sponsor: Guy's and St Thomas' NHS Foundation Trust
- | everolimus / Generic mfg.
Journal: Efficacy of everolimus plus hormonal treatment after cyclin-dependent kinase inhibitor; real-life experience, A TOG study. (Pubmed Central) - Oct 29, 2024
EVE combinations may be more appropriate for patients with non-liver metastasis, and the first treatment response shows the benefit of treatment. In addition, immediate treatment after CDKi treatment is more beneficial than later lines of treatment.
- | Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
Journal: Usage status of biologics for the chronic treatment of optic neuritis in neuromyelitis optica spectrum disorders in Japan. (Pubmed Central) - Oct 29, 2024
Satralizumab was the most commonly used biologic for AQP4-Ab positive optic neuritis in Japan. This study demonstrates the efficacy and safety of satralizumab in preventing the relapse of optic neuritis.
- | elraglusib (9-ING-41) / Actuate Therap
Journal: Elraglusib induces cytotoxicity via direct microtubule destabilization independently of GSK3 inhibition. (Pubmed Central) - Oct 29, 2024
In summary, elraglusib acts as a direct microtubule destabilizer both in vitro and across multiple cancer types, resulting in mitotic arrest, DNA damage and apoptosis. These effects likely account for its broad pan-cancer activity, which does not rely upon GSK3 inhibition as they are not replicated by other GSK3 inhibitors.
- || Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal, IO biomarker: Philadelphia chromosome-positive or Philadelphia chromosome-like B-cell precursor acute lymphoblastic leukemia with multilineage involvement in pediatric patients: a report of two cases and literature review. (Pubmed Central) - Oct 29, 2024
Using droplet digital PCR, BCR::ABL1 or TPM3::PDGFRB transcripts were identified in CD19+ cells as well as in non-CD19+ cells, suggesting the presence of a Ph+ or Ph-like ALL-M subtype originating from hematopoietic stem cells. This report provides information for better characterization, diagnosis, and treatment of these ALL subtypes.
- | Vyepti (eptinezumab-jjmr) / Teva, Lundbeck
Retrospective data, Journal: Efficacy of eptinezumab in non-responders to subcutaneous monoclonal antibodies against CGRP and the CGRP receptor: A retrospective cohort study. (Pubmed Central) - Oct 29, 2024
This report provides information for better characterization, diagnosis, and treatment of these ALL subtypes. Eptinezumab may be an effective and well-tolerated option for some treatment-refractory migraine patients unresponsive to subcutaneous CGRP-(R) mAbs.
- | Ibrance (palbociclib) / Pfizer
Journal, Metastases: Experience With Palbociclib in Metastatic Breast Cancer Patients Managed Under a Government Health Scheme at a Cancer Care Center in Southern India. (Pubmed Central) - Oct 29, 2024
However, in developing countries like India, where most patients come from rural areas, using innovator palbociclib may not be feasible for many. With the availability of generic palbociclib under the Government Health Scheme, patients of metastatic hormone receptor-positive breast cancer will receive the protocol-based treatment.
- | Enbrel (etanercept) / Pfizer, Amgen
Journal: Unexpected multiple sclerosis-like symptoms in a rheumatoid arthritis patient treated with Etanercept: A case report. (Pubmed Central) - Oct 29, 2024
Rapid clinical improvement was noted and in the approximately 6-month follow-up, she did not exhibit any neurological worsening. So it is probable that the initiation of Etanercept triggered MS-like syndrome in these patients and healthcare practitioners should take heed of this adverse effect.
- || Repatha (evolocumab) / Amgen, Astellas
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of Evolocumab in Cardiovascular Disease: A Systematic Review. (Pubmed Central) - Oct 29, 2024
Future studies should investigate the economic impact's certainty and uncertainty, and consider different countries' income levels. LDL-C levels, medication costs, and CVD types are important factors affecting cost-effectiveness analysis.
- ||| zeluvalimab (AMG 404) / Amgen, etevritamab (AMG 596) / Amgen
Trial termination, Combination therapy, Monotherapy: Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - Oct 29, 2024
P1, N=30, Terminated, Sponsor: Amgen
LDL-C levels, medication costs, and CVD types are important factors affecting cost-effectiveness analysis. Completed --> Terminated; Amgen business decision
- MCC1 TCR - Fred Hutchinson Cancer Center, Affini / T Therap, Regeneron
Trial completion date, Trial termination, Metastases, Immune cell: ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov) - Oct 29, 2024
P1/2, N=7, Terminated, Sponsor: Fred Hutchinson Cancer Center
Completed --> Terminated; Amgen business decision Trial completion date: Jan 2025 --> Jan 2024 | Active, not recruiting --> Terminated; Terminated due to insufficient funding
- ||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion, Metastases: Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017) (clinicaltrials.gov) - Oct 28, 2024
P3, N=480, Completed, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jan 2025 --> Jan 2024 | Active, not recruiting --> Terminated; Terminated due to insufficient funding Active, not recruiting --> Completed
- | Ibrance (palbociclib) / Pfizer, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Phase classification, Trial completion date, Trial primary completion date, Metastases: HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer (clinicaltrials.gov) - Oct 28, 2024
P1, N=54, Active, not recruiting, Sponsor: Abramson Cancer Center at Penn Medicine
Active, not recruiting --> Completed Phase classification: P1/2 --> P1 | Trial completion date: Apr 2024 --> Dec 2024 | Trial primary completion date: Apr 2024 --> Dec 2024
- | Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
Journal, IO biomarker: B cell and aquaporin-4 antibody relationships with neuromyelitis optica spectrum disorder activity. (Pubmed Central) - Oct 28, 2024
P2/3
With inebilizumab treatment, B-cell subset counts decreased and did not increase with attacks. No difference in change of AQP4-IgG titers from baseline to time of attack was observed.
- | Tavneos (avacopan) / Amgen
Journal: Case report: Avacopan-induced severe liver injury with prolonged jaundice and lipoprotein X-induced dyslipidemia. (Pubmed Central) - Oct 28, 2024
No difference in change of AQP4-IgG titers from baseline to time of attack was observed. No abstract available
- | Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Response to the Letter to the Editor regarding "The effect of romosozumab on bone mineral density depending on prior treatment: a prospective, multicentre cohort study in Switzerland" by Yang and colleagues. (Pubmed Central) - Oct 28, 2024
No abstract available No abstract available
- | Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Letter to the Editor Regarding "The effect of romosozumab on bone mineral density depending on prior treatment: a prospective, multicentre cohort study in Switzerland". (Pubmed Central) - Oct 28, 2024
No abstract available No abstract available
- | Ibrance (palbociclib) / Pfizer, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, IO biomarker: Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma (clinicaltrials.gov) - Oct 28, 2024
P2, N=77, Active, not recruiting, Sponsor: Alliance for Clinical Trials in Oncology
No abstract available Recruiting --> Active, not recruiting
- | Blincyto (blinatumomab) / Astellas, Amgen
New trial: Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov) - Oct 28, 2024
P=N/A, N=30, Not yet recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital, China
- |||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Enrollment open: ARRIVAL: Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (clinicaltrials.gov) - Oct 28, 2024
P3, N=300, Recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||| bemarituzumab (AMG 552) / Amgen
Trial termination, Monotherapy: A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (clinicaltrials.gov) - Oct 28, 2024
P1, N=74, Terminated, Sponsor: Amgen
Not yet recruiting --> Recruiting Completed --> Terminated; Business decision not due to safety concerns
- | Epogen (epoetin alfa) / Amgen
Retrospective data, Journal: Efficacy of Epoetin Alfa in Managing Symptomatic Anaemia in Low-Risk Myelodysplastic Syndromes: A Retrospective Analysis. (Pubmed Central) - Oct 28, 2024
Completed --> Terminated; Business decision not due to safety concerns Epoetin alfa (Eprex
- || Imlygic (talimogene laherparepvec) / Amgen
New P1 trial: Neoadjuvant Intralesional Injection of Talimogene Laherparepvec (clinicaltrials.gov) - Oct 28, 2024
P1, N=30, Not yet recruiting, Sponsor: John Rieth
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen
Trial completion date: Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma (clinicaltrials.gov) - Oct 28, 2024
P3, N=479, Active, not recruiting, Sponsor: Children's Oncology Group
Epoetin alfa (Eprex Trial completion date: Sep 2024 --> Dec 2025
- | Nplate (romiplostim) / Amgen
New P2 trial: A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP (clinicaltrials.gov) - Oct 28, 2024
P2, N=129, Recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital, China
- ||| BAY-3498264 / Bayer
New P1 trial, Metastases: A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation (clinicaltrials.gov) - Oct 28, 2024
P1, N=104, Not yet recruiting, Sponsor: Bayer
- ||||| maridebart cafraglutide (AMG 133) / Amgen
New P2 trial: A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - Oct 27, 2024
P2, N=350, Not yet recruiting, Sponsor: Amgen
- | Neulasta (pegfilgrastim) / Roche
Journal: Investigation of the Changes in Blood Cell Components following the Administration of Pegfilgrastim in Neo-Adjuvant and Adjuvant FEC Chemotherapy for Breast Cancer (Pubmed Central) - Oct 27, 2024
Perioperative fluorouracil, epirubicin and cyclophosphamide(FEC)therapy is a standard treatment for breast cancer...The incidence of FN was 6.5% with pegfilgrastim administration and 22.8% without pegfilgrastim administration(p=0.020). Primary prophylaxis with pegfilgrastim can reduce the incidence of FN and can be safely used for 1 year after initial administration in patients with breast cancer undergoing chemotherapy.