Delving into the Latest Updates on Balugrastim(Teva Biopharmaceuticals USA, Inc.) with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Albugranin, Albumin fused G-CSF, Balugrastim

+ [8]

Target

CSF-3R

Action

agonists, stimulants

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists), Haematopoiesis stimulants

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication-

Inactive Indication

Neutropenia

Originator Organization

Teva Biopharmaceuticals USA, Inc.

Active Organization-

Inactive Organization

Teva Pharmaceutical Industries Ltd.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 9693373

Source: *****

AbstractObjectives.This study aimed to evaluate the efficacy and safety of once-per-cycle balugrastim versus pegfilgrastim for neutrophil support in breast cancer patients receiving myelosuppressive chemotherapy.Methods.Breast cancer patients (n = 256) were randomized to 40 or 50 mg of subcutaneous balugrastim or 6 mg of pegfilgrastim ≈24 hours after chemotherapy (60 mg/m2 doxorubicin and 75 mg/m2 docetaxel, every 21 days for up to 4 cycles). The primary efficacy parameter was the duration of severe neutropenia (DSN) in cycle 1. Secondary parameters included DSN (cycles 2–4), absolute neutrophil count (ANC) nadir, febrile neutropenia rates, and time to ANC recovery (cycles 1–4). Safety, pharmacokinetics, and immunogenicity were assessed.Results.Mean cycle 1 DSN was 1.0 day with 40 mg of balugrastim, 1.3 with 50 mg of balugrastim, and 1.2 with pegfilgrastim (upper limit of 95% confidence intervals for between-group DSN differences was <1.0 day for both balugrastim doses versus pegfilgrastim). Between-group efficacy parameters were comparable except for time to ANC recovery in cycle 1 (40 mg of balugrastim, 2.0 days; 50 mg of balugrastim, 2.1; pegfilgrastim, 2.6). Median terminal elimination half-life was ≈37 hours for 40 mg of balugrastim, ≈36 for 50 mg of balugrastim, and ≈45 for pegfilgrastim. Antibody response to balugrastim was low and transient, with no neutralizing effect.Conclusion.Once-per-cycle balugrastim is not inferior to pegfilgrastim in reducing cycle 1 DSN in breast cancer patients receiving chemotherapy; both drugs have comparable safety profiles.

01 Jun 2015·Medical OncologyQ4 · MEDICINE

Phase II dose-finding study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy

Q4 · MEDICINE

Article

Author: Liat Adar ; Peter Bias ; Igor N. Bondarenko ; Oleg Gladkov ; Noa Avisar ; Vladimir Moiseyenko ; Steven Barash ; Yaroslav Shparyk

Balugrastim is a once-per-cycle, fixed-dose recombinant protein comprising human serum albumin and granulocyte colony-stimulating factor under development for prevention of severe neutropenia in cancer patients receiving myelosuppressive chemotherapy. This phase II, multicenter, active-controlled, dose-finding pilot study evaluated balugrastim safety and efficacy versus pegfilgrastim in breast cancer patients scheduled to receive myelosuppressive chemotherapy and investigated two doses with similar efficacy to pegfilgrastim for a subsequent phase III study. Patients received four cycles of doxorubicin/docetaxel chemotherapy and with each successive cycle were randomized sequentially to escalating doses of balugrastim [30 (n = 11), 40 (n = 21), or 50 mg (n = 20)] or a fixed dose of pegfilgrastim [6 mg (n = 26)] post-chemotherapy. Balugrastim doses were escalated as planned. The incidence of adverse events was similar among the balugrastim groups and between all balugrastim doses and pegfilgrastim. The most frequently reported adverse events were neutropenia, alopecia, and nausea. During cycle 1, severe neutropenia (absolute neutrophil count of <0.5 × 10(9)/L) occurred in 40, 67, and 50 % and febrile neutropenia occurred in 20.0, 9.5, and 10.0 % of patients receiving balugrastim 30, 40, and 50 mg, respectively; in patients receiving pegfilgrastim, 48 % experienced severe neutropenia and 8 % experienced febrile neutropenia. Duration of severe neutropenia (DSN) for each treatment group was 0.9, 1.6, 1.1, and 0.9 days, respectively. In the remaining three chemotherapy cycles, DSN was ≤1 day across all treatment groups. Balugrastim 50 mg was comparable to pegfilgrastim in terms of safety and overall efficacy in breast cancer patients receiving myelosuppressive chemotherapy.

01 May 2015·Cancer Chemotherapy and PharmacologyQ4 · MEDICINE

First-in-human, phase I/IIa dose-escalation and safety study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy

Q4 · MEDICINE

Article

Author: Udo Müller ; Liat Adar ; Jason Bock ; David Shen ; Laurie Pukac ; Noa Avisar ; Steve Barash

PURPOSETo evaluate safety of balugrastim, a recombinant human serum albumin and granulocyte colony-stimulating factor (G-CSF), administered over a range of therapeutic doses in women with breast cancer receiving doxorubicin plus docetaxel chemotherapy.METHODSThe phase I, sequential dose-escalation first segment compared subcutaneous balugrastim 50, 150, 300, and 450 µg/kg during chemotherapy cycles 0-2. The randomized (2:2:1), open-label, phase IIa second segment compared balugrastim 300 or 450 µg/kg with pegfilgrastim 6 mg during chemotherapy cycles 1 and 2.RESULTSIn the phase I segment, balugrastim was escalated to 450 µg/kg in 13 patients without dose-limiting toxicity. Three (9.7 %) of the 31 adverse events (AEs) reported in nine patients were grade 3 (agranulocytosis, vomiting, hypertension); none was grade 4. In the open-label phase IIa segment (N = 51), the majority of the 64 AEs reported in 31 (75.6 %) balugrastim-treated patients were grade 1 (59.4 %), with 39.1 % grade 2, 1.6 % grade 3 (one AE of vomiting), and none grade 4. Of the 16 AEs reported in seven (70.0 %) pegfilgrastim-treated patients, 87.5 % were grade 1, 6.3 % were grade 2, 6.3 % were grade 3 (one AE of thrombocytopenia), and none were grade 4. Overall, there were six bone pain AEs reported, one in the balugrastim 300 µg/kg group and five in the balugrastim 450 µg/kg group. No AEs in either study necessitated treatment interruption/discontinuation. The incidence and duration of grade 3-4 neutropenia were similar between balugrastim- and pegfilgrastim-treated patients.CONCLUSIONSBalugrastim was well tolerated in this small population of breast cancer patients.

100 Deals associated with Balugrastim(Teva Biopharmaceuticals USA, Inc.)

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External Link

KEGG	Wiki	ATC	Drug Bank
D10310	-	L03AA15	DB12699

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	Phase 3	-	Teva Pharmaceutical Industries Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2012	Not Applicable	Breast Cancer	-	Balugrastim 40 mg	(ruljwignix) = delqixjmea xyybzylzrq (oedbsxqmgn )	Positive	20 May 2012
				Pegfilgrastim 6 mg	(ruljwignix) = hixdixtfcw xyybzylzrq (oedbsxqmgn )
ASCO2011	Phase 2/3	Breast Cancer	334	CG-10639 40mg	(srotuzmfcl) = qxveqzuthp fwfhdoipdz (tuzmozkshk )	Positive	20 May 2011
				CG-10639 50mg	(srotuzmfcl) = lhsfsbqaln fwfhdoipdz (tuzmozkshk )
SICOG 9908 (ASCO2004)	Phase 3	Metastatic breast cancer	132	PET (cisplatin 30 mg/m2/week + epirubicin 50 gm/m2/week + paclitaxel 120 mg/m2/week + G-CSF)	(mpazcqrnzt) = Anaemia was substantially more frequent in the PET arm txnvovbmxw (jzydkgufuk ) View more	Positive	15 Jul 2004
				ET (epirubicin 90 mg/m2/ + paclitaxel 175 mg/m2)
SICOG 9908 (ASCO2004)	Phase 3	Locally advanced breast cancer	160	PET (cisplatin 30 mg/m2/week + epirubicin 50 mg/m2/week + paclitaxel 120 mg/m2/week + G-CSF)	slxvhojsco(apdhiiaoib) = substantially more frequent in the PET arm ykmglpacyx (szivigukfk ) View more	Positive	15 Jul 2004
				ET (epirubicin 90 mg/m2/ + paclitaxel 175 mg/m2)

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Balugrastim(Teva Biopharmaceuticals USA, Inc.)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation