*Unless there is disease progression or unacceptable toxicity.
†Hospitalization may be needed to manage select AEs in some patients.
Recommendations for restarting therapy with LUNSUMIO after dose delay1 | ||
---|---|---|
Last Dose Administered | Time Since the Last Dose Administered | Action for Next Dose(s) |
1 mg Cycle 1 Day 1 |
1 to 2 weeks | Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule. |
>2 weeks | Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule. | |
2 mg Cycle 1 Day 8 |
1 to 2 weeks | Administer 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule. |
>2 weeks to <6 weeks | Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
≥6 weeks | Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
60 mg Cycle 1 Day 15 |
1 week to <6 weeks | Administer 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule. |
≥6 weeks | Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1) and then resume the planned treatment schedule. | |
60 mg Cycle 2 Day 1 |
3 weeks to <6 weeks | Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule. |
≥6 weeks | Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15)*, followed by 30 mg (Cycle 4 Day 1) and then resume the planned treatment schedule. | |
30 mg Cycle 3 onwards |
3 weeks to <6 weeks | Administer 30 mg, then resume the planned treatment schedule. |
≥6 weeks | Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15*, followed by 30 mg on Day 1 of subsequent cycles. |
*For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per the Recommended Premedications table for all patients.
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AE=adverse event; CR=complete response; PR=partial response; SD=stable disease.
LUNSUMIO. Prescribing Information. Genentech, Inc.
LUNSUMIO. Prescribing Information. Genentech, Inc.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. News release. July 14, 2020. Accessed December 17, 2021.
https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
FDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. News release. July 14, 2020. Accessed December 17, 2021.
https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm.
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.
Sun LL, Ellerman D, Mathieu M, et al. Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015;7(287):287ra70. doi:10.1126/scitranslmed.aaa4802.
Sun LL, Ellerman D, Mathieu M, et al. Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015;7(287):287ra70. doi:10.1126/scitranslmed.aaa4802.
Ferl GZ, Reyes A, Sun LL, et al. A preclinical population pharmacokinetic model for anti-CD20/CD3 T-cell-dependent bispecific antibodies. Clin Transl Sci. 2018;11(3):296-304. doi:10.1111/cts.12535.
Ferl GZ, Reyes A, Sun LL, et al. A preclinical population pharmacokinetic model for anti-CD20/CD3 T-cell-dependent bispecific antibodies. Clin Transl Sci. 2018;11(3):296-304. doi:10.1111/cts.12535.
BLA Multi-disciplinary Review and Evaluation {BLA 761263, Lunsumio (Mosunetuzumab)}. US Food and Drug Administration. January 2020. Accessed May 14, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761263Orig1s000MultidisciplineR.pdf.
BLA Multi-disciplinary Review and Evaluation {BLA 761263, Lunsumio (Mosunetuzumab)}. US Food and Drug Administration. January 2020. Accessed May 14, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761263Orig1s000MultidisciplineR.pdf.
Schuster SJ, Sehn LH, Bartlett NL, et al. Mosunetuzumab monotherapy continues to demonstrate durable responses in patients with relapsed and/or refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study. Presented at: The 65th American Society of Hematology Annual Meeting. December 9-12, 2023. Oral presentation.
Schuster SJ, Sehn LH, Bartlett NL, et al. Mosunetuzumab monotherapy continues to demonstrate durable responses in patients with relapsed and/or refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study. Presented at: The 65th American Society of Hematology Annual Meeting. December 9-12, 2023. Oral presentation.
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