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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Novex (rituximab biosimilar)
i
Other names: RTXM83, mAbx-02, MB01
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News alerts, weekly reports and conference planners
Company:
Elea Labs, Insud Pharma, Laboratorios Bioeticos, NATCO, Pharmaceutical Libbs, PiSA Farmaceutica, Urufarma
Drug class:
CD20 inhibitor
Related drugs:
almost2years
Retrospective Observational Study of the Long-Term Safety and Efficacy Outcomes of Rituximab Biosimilar: Partial Data of RTXM83-AC-01-11 Subanalysis Study (ASH 2022)
One participant of the RTXM83-CHOP arm had a SAE classified as severe infection related to rituximab (hypogammaglobulinemia). From the R-CHOP/MabThera® 1 participant displayed 1 SAE (secondary neoplasm) with a possible relationship to rituximab.Conclusion The partial analysis of the LB2002 has demonstrated thus far the safety profile of the biosimilar RTXM83 (Vivaxxia®) in the Brazilian population is consistent with the known safety profile of rituximab.
Observational data • Retrospective data
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CD20 (Membrane Spanning 4-Domains A1)
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Rituxan (rituximab) • Novex (rituximab biosimilar)
4years
Clinical • Enrollment change • PD(L)-1 Biomarker
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CD20 (Membrane Spanning 4-Domains A1)
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Keytruda (pembrolizumab) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • Novex (rituximab biosimilar)
4years
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma (clinicaltrials.gov)
P2; N=45; Not yet recruiting; Sponsor:Academic and Community Cancer Research United
New P2 trial • Clinical
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CD34 (CD34 molecule)
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clonoSEQ
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Rituxan (rituximab) • cytarabine • bortezomib • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • prednisone • daunorubicin • Rituxan Hycela (rituximab/hyaluronidase) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Novex (rituximab biosimilar) • cyclophosphamide intravenous
4years
Rituximab, Pembrolizumab, and Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma (clinicaltrials.gov)
Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2021 --> Feb 2023
Clinical • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker
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CD20 (Membrane Spanning 4-Domains A1)
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Keytruda (pembrolizumab) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • Novex (rituximab biosimilar)
5years
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov)
P2; Not yet recruiting --> Recruiting
Enrollment open • Clinical
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CCND1 (Cyclin D1) • CD34 (CD34 molecule)
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CCND1 expression
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clonoSEQ
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Rituxan (rituximab) • cytarabine • Calquence (acalabrutinib) • bendamustine • Belrapzo (bendamustine RTD) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Novex (rituximab biosimilar)
5years
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov)
P2; N=369; Not yet recruiting; Sponsor:ECOG-ACRIN Cancer Research Group
New P2 trial • Clinical
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CCND1 (Cyclin D1) • CD34 (CD34 molecule)
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CCND1 expression
|
clonoSEQ
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Rituxan (rituximab) • cytarabine • Calquence (acalabrutinib) • bendamustine • Belrapzo (bendamustine RTD) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Novex (rituximab biosimilar)
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