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- Rolvedon (eflapegrastim-xnst) / Assertio
Eflapegrastim, a Long-Acting Granulocyte Colony () - Apr 14, 2025 - Abstract #MBCC2025MBCC_248;
P1, P3
Eflapegrastim
- Rolvedon (eflapegrastim-xnst) / Assertio, Granocyte (lenograstim) / Roche, Neulasta (pegfilgrastim) / Roche
Effect of Granulocyte Colony Stimulating Factor (GCSF) on Survival in Patients with Acute Myeloid Leukemia (AML) () - Dec 7, 2024 - Abstract #ASH2024ASH_8071;
Overall survival was also shorter for patients who received GCSF. GCSF should be used very diligently in AML cases.
- Rolvedon (eflapegrastim-xnst) / Assertio
Eflapegrastim, a long-acting GCSF, administered the same day as chemotherapy in patients with early-stage breast cancer: Results from a multicenter, open-label, study (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1762;
- ||| Rolvedon (eflapegrastim-xnst) / Assertio
Trial completion: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Sep 20, 2024
P1, N=59, Completed, Sponsor: Spectrum Pharmaceuticals, Inc
GCSF should be used very diligently in AML cases. Active, not recruiting --> Completed
- | Ryzneuta (efbemalenograstim alpha) / Yifan Pharma
Journal: Ryzneuta for prevention of febrile neutropenia. (Pubmed Central) - Aug 13, 2024
Active, not recruiting --> Completed No abstract available
- || Rolvedon (eflapegrastim-xnst) / Assertio
Enrollment closed: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - May 16, 2024
P1, N=50, Active, not recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
No abstract available Recruiting --> Active, not recruiting
- Rolvedon (eflapegrastim-xnst) / Assertio
Comparative analysis of efficacy and safety profiles between conventional pegfilgrastim and its biosimilar agents in patients receiving cytotoxic chemotherapy: A systemic review and meta-analysis. (Hall A; Poster Bd #: 244) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2863;
Growing evidence supports cost-effective biosimilars of pegfilgrastim as comparable in efficacy and safety. Eflapegrastim emerges as a promising alternative, demonstrating a clinically meaningful benefit over the conventional pegfilgrastim.
- | Rolvedon (eflapegrastim-xnst) / Assertio
Trial completion date, Trial primary completion date: A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (clinicaltrials.gov) - Mar 2, 2024
P2, N=40, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Eflapegrastim emerges as a promising alternative, demonstrating a clinically meaningful benefit over the conventional pegfilgrastim. Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Jul 2025 --> Oct 2027
- || Rolvedon (eflapegrastim-xnst) / Assertio
Enrollment change, Trial completion date, Trial primary completion date: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Mar 1, 2024
P1, N=50, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Jul 2025 --> Oct 2027 N=90 --> 50 | Trial completion date: Jun 2025 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024
- ||| Rolvedon (eflapegrastim-xnst) / Assertio, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: NEUTHREE: Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (clinicaltrials.gov) - Feb 23, 2024
P4, N=100, Recruiting, Sponsor: Eunseong Medical Foundation Good GANG-AN HOSPITAL
N=90 --> 50 | Trial completion date: Jun 2025 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024 Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Jul 2025 | Initiation date: Aug 2023 --> Nov 2023 | Trial primary completion date: Jul 2024 --> Jan 2025
- || Rolvedon (eflapegrastim-xnst) / Spectrum Pharma, Lonquex (lipegfilgrastim biosimilar) / Teva
Retrospective data, Review, Journal: Assessing the Optimal Regimen: A Systematic Review and Network Meta-Analysis of the Efficacy and Safety of Long-Acting Granulocyte Colony-Stimulating Factors in Patients with Breast Cancer. (Pubmed Central) - Jul 29, 2023
For patients with breast cancer, lipegfilgrastim 6 mg and eflapegrastim 13.2 mg might be the most effective regimen among LA-G-CSFs. Higher doses of LA-G-CSF may enhance efficacy without causing additional SAEs.
- |||| Rolvedon (eflapegrastim-xnst) / Assertio, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
New P4 trial: NEUTHREE: Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (clinicaltrials.gov) - Jul 20, 2023
P4, N=100, Not yet recruiting, Sponsor: Eunseong Medical Foundation Good GANG-AN HOSPITAL
- ||| Rolvedon (eflapegrastim-xnst) / Spectrum Pharma, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
P3 data, Journal: Eflapegrastim Versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies. (Pubmed Central) - Jul 14, 2023
Higher doses of LA-G-CSF may enhance efficacy without causing additional SAEs. This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.
- || Rolvedon (eflapegrastim-xnst) / Spectrum Pharma
FDA event, Review, Journal: FDA Approvals of Biologics in 2022. (Pubmed Central) - May 27, 2023
We not only apply a quantitative analysis to this year's harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes.
- | Rolvedon (eflapegrastim-xnst) / Spectrum Pharma
Journal: Eflapegrastim (Rolvedon) for prevention of chemotherapy-induced febrile neutropenia. (Pubmed Central) - May 26, 2023
On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes. No abstract available
- | Rolvedon (eflapegrastim-xnst) / Spectrum Pharma
Journal: Eflapegrastim-xnst. (Pubmed Central) - Mar 9, 2023
No abstract available No abstract available
- ||| Rolvedon (eflapegrastim-xnst) / Spectrum Pharma
Reimbursement, US reimbursement, Medicare, Medicaid: $SPPI Spectrum Pharmaceuticals Receives Permanent J-Code for ROLVEDON™ (eflapegrastim-xnst) Injection (J1449) from U.S. Centers for Medicare & Medicaid Services https://t.co/VFj43GKyAZ (Twitter) - Feb 7, 2023
- || Rolvedon (eflapegrastim-xnst) / Assertio
Enrollment change, Trial completion date, Trial primary completion date: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Nov 9, 2022
P1, N=90, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
No abstract available N=45 --> 90 | Trial completion date: Jan 2022 --> Jun 2025 | Trial primary completion date: May 2021 --> Dec 2024
- || FDA event: In September 2022, the #FDA granted 7 approvals, including durvalumab, eflapegrastim-xnst, sodium thiosulfate, selpercatinib, futibatinib, and more. https://t.co/KxQFOWgM9b (Twitter) - Oct 4, 2022
- ||| Rolvedon (eflapegrastim) / Spectrum Pharma
FDA event: FDA Approves Eflapegrastim for Chemo-Induced Neutropenia https://t.co/IKljefVe0L via @onclive (Twitter) - Oct 2, 2022
- || Cosela (trilaciclib) / G1 Therap, Rolontis (eflapegrastim) / Spectrum Pharma, Ryzneuta (efbemalenograstim alpha) / Yifan Pharma
Review, Journal: Chemotherapy-induced neutropenia and emerging agents for prevention and treatment: A review. (Pubmed Central) - Aug 24, 2022
N=45 --> 90 | Trial completion date: Jan 2022 --> Jun 2025 | Trial primary completion date: May 2021 --> Dec 2024 No abstract available
- ||| Rolontis (eflapegrastim) / Spectrum Pharma
FDA event: $SPPI Spectrum Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Eflapegrastim https://t.co/tLE2fUga8U (Twitter) - Apr 11, 2022
- || Rolontis (eflapegrastim) / Spectrum Pharma, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Clinical, PK/PD data, Journal: A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. (Pubmed Central) - Mar 3, 2022
P1
In both ethnic groups, eflapegrastim showed dose-dependent PK and the exposure to eflapegrastim was positively correlated with ANC and CD34 cell count. The comparable PK and PD profiles of eflapegrastim in Japanese and Caucasian subjects may indicate the same dosage regimen is acceptable.
- || Rolontis (eflapegrastim) / Spectrum Pharma, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Clinical, Journal: Justification for a Fixed Dose of Eflapegrastim, a Long-Acting G-CSF, in Patients Receiving Docetaxel-Cyclophosphamide Chemotherapy. (Pubmed Central) - Dec 16, 2021
Body weight had no clinically significant effect on response, justifying administration of a fixed dose of eflapegrastim. The results from 2 phase 3 studies demonstrate that eflapegrastim at a fixed dose of 13.2 mg (3.6 mg G-CSF) administered once per chemotherapy cycle is effective in prophylactic treatment of chemotherapy-induced neutropenia.
- || Rolvedon (eflapegrastim-xnst) / Assertio
Enrollment open: A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (clinicaltrials.gov) - Sep 9, 2021
P2, N=40, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
The results from 2 phase 3 studies demonstrate that eflapegrastim at a fixed dose of 13.2 mg (3.6 mg G-CSF) administered once per chemotherapy cycle is effective in prophylactic treatment of chemotherapy-induced neutropenia. Not yet recruiting --> Recruiting
- || FDA event: Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor https://t.co/GhrbcfwQwI #PinkSheet (Twitter) - Aug 7, 2021
- ||| Rolontis (eflapegrastim) / Spectrum Pharma, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
P3 data, Journal: Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial. (Pubmed Central) - Jun 22, 2021
In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, we discerned noninferiority and comparable safety for eflapegrastim and pegfilgrastim. Nevertheless, the risk of CIN remains a momentous concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.
- | Rolvedon (eflapegrastim-xnst) / Assertio
Trial initiation date: A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (clinicaltrials.gov) - Jun 15, 2021
P2, N=40, Not yet recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Nevertheless, the risk of CIN remains a momentous concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations. Initiation date: Sep 2020 --> Jun 2021
- ||| Rolontis (eflapegrastim) / Spectrum Pharma, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Clinical, P3 data, Journal: A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study. (Pubmed Central) - Jun 8, 2021
Patients with Stage I to IIIA early-stage breast cancer (ESBC) were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or pegfilgrastim (6 mg G-CSF) administered one day after standard docetaxel/cyclophosphamide (TC) therapy for four cycles...The results demonstrate noninferior efficacy and comparable safety for eflapegrastim, at a lower G-CSF dose, vs pegfilgrastim. The potential for the increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study.
- || Rolontis (eflapegrastim) / Spectrum Pharma
$SPPI Spectrum Pharmaceuticals Announces That the ROLONTIS® (eflapegrastim) Pre-Approval Inspection Has Been Initiated https://t.co/6gUdz0TAHU (Twitter) - Jun 1, 2021
- || Rolontis (eflapegrastim) / Spectrum Pharma, poziotinib (HM 78136B) / Spectrum Pharma, Hanmi
FDA event, NDA: $SPPI Poziotinib NDA on track for 2021 submission FDA pre-approval inspection at the ROLONTIS manufacturing facility scheduled for May (Twitter) - May 13, 2021
- | Rolontis (eflapegrastim) / Spectrum Pharma
$SPPI Pre-Approval Inspection of ROLONTIS Manufacturing Facility in May (Twitter) - Mar 30, 2021
- || Rolontis (eflapegrastim) / Spectrum Pharma
FDA event: $SPPI Provides Update on ROLONTIS Pre-Approval Inspection. FDA has scheduled the pre-approval inspection in May. (Twitter) - Mar 16, 2021
- Rolontis (eflapegrastim) / Spectrum Pharma
[VIRTUAL] Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients () - Mar 11, 2021 - Abstract #AACR2021AACR_2560;
Results to date from both nonclinical and clinical studies were similar and support our hypothesis that the higher and more sustained marrow resident time of Efla appears to provide an effective prophylaxis against severe neutropenia when administered on the same day as CT. The 0.5 hour cohort of the study is being expanded to confirm these promising results.
- | Rolontis (eflapegrastim) / Spectrum, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Preclinical, Journal: Eflapegrastim Enhanced Efficacy Compared to Pegfilgrastim in Neutropenic Rats Supports Potential for Same-Day Dosing. (Pubmed Central) - Jan 15, 2021
Neutropenia was induced in rats via intraperitoneal cyclophosphamide or docetaxel/cyclophosphamide...Eflapegrastim's greater marrow resident time provided a pharmacodynamic advantage over pegfilgrastim translating into shortened duration of neutropenia. Our findings support eflapegrastim same day administration with chemotherapy warranting evaluation in patients undergoing myelosuppressive chemotherapy.
- Rolontis (eflapegrastim) / Spectrum, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
[VIRTUAL] Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia after Same-Day Dosing of Eflapegrastim in Patients with Breast Cancer Receiving Docetaxel and Cyclophosphamide (NCT04187898) () - Nov 5, 2020 - Abstract #ASH2020ASH_5468;
P1
Target Accrual: 45 patients (15 subjects/arm). Enrollment began in April 2020.
- | Rolontis (eflapegrastim) / Spectrum
$SPPI Q3. No update on ROLONTIS BLA. https://t.co/yKeGujFcLI (Twitter) - Nov 4, 2020
- || Rolontis (eflapegrastim) / Spectrum
$SPPI Announces that the FDA is Deferring its Action on the BLA for ROLONTIS Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions (Twitter) - Oct 26, 2020
- || Rolvedon (eflapegrastim-xnst) / Assertio
New P2 trial: A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (clinicaltrials.gov) - Sep 29, 2020
P2, N=40, Not yet recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
- | Rolvedon (eflapegrastim-xnst) / Assertio
Trial primary completion date: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Aug 7, 2020
P1, N=45, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Enrollment began in April 2020. Trial primary completion date: Oct 2020 --> May 2021
- || Rolontis (eflapegrastim) / Spectrum
#SpectrumPharmaceuticals Presents Same Day Dosing Data for #ROLONTIS® (#Eflapegrastim) at #AACR20 $SPPI https://t.co/nyvLBixRaV (Twitter) - Jun 23, 2020
- | Rolvedon (eflapegrastim-xnst) / Assertio
Trial completion date: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Mar 3, 2020
P1, N=45, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Trial primary completion date: Oct 2020 --> May 2021 Trial completion date: Oct 2020 --> Jan 2022
- ||||||| Rolvedon (eflapegrastim-xnst) / Assertio
Trial completion, Trial completion date: RECOVER: SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide (clinicaltrials.gov) - Jan 15, 2020
P3, N=237, Completed, Sponsor: Spectrum Pharmaceuticals, Inc
Trial completion date: Oct 2020 --> Jan 2022 Active, not recruiting --> Completed | Trial completion date: Apr 2019 --> Jul 2019
- || Rolvedon (eflapegrastim-xnst) / Assertio
Enrollment open: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Jan 13, 2020
P1, N=45, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Active, not recruiting --> Completed | Trial completion date: Apr 2019 --> Jul 2019 Not yet recruiting --> Recruiting
- || Rolontis (eflapegrastim) / Spectrum
@US_FDA to Review Eflapegrastim for Chemo-Induced Neutropenia https://t.co/r8HNcadFtJ (Twitter) - Jan 2, 2020
- || Rolontis (eflapegrastim) / Spectrum
PDUFA date: $SPPI FDA accepts BLA for ROLONTIS. PDUFA 10/24/20 (Twitter) - Dec 26, 2019
- || Rolvedon (eflapegrastim-xnst) / Assertio
New P1 trial: Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (clinicaltrials.gov) - Dec 4, 2019
P1, N=45, Not yet recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
- || Rolontis (eflapegrastim) / Spectrum
BLA: #SpectrumPharmaceuticals Announces Submission to the U.S. #FDA of Updated #BiologicsLicenseApplication for #ROLONTIS® $SPPI https://t.co/Vg0TGqQi9a (Twitter) - Oct 27, 2019
- || Rolontis (eflapegrastim) / Spectrum
Eflapegrastim Application Resubmitted to FDA for Chemo-Induced Neutropenia https://t.co/3bAeXF6y5k (Twitter) - Oct 25, 2019
- | Rolontis (eflapegrastim) / Spectrum Pharma, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Clinical, Journal: An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. (Pubmed Central) - Sep 8, 2019
This randomized, open-label, active-controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid growth factor, versus pegfilgrastim in breast cancer patients being treated with docetaxel and cyclophosphamide (TC)...All doses of Rolontis were well tolerated, and no new or significant treatment-related toxicities were observed. In Cycle 1, Rolontis demonstrated noninferiority at the 135 μg/kg dose and statistical superiority in DSN at the 270 μg/kg dose when compared to pegfilgrastim.