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This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.
Despite recent therapeutic advances, the unmet need remains high for patients with 3L+ R/R DLBCL1-4
Most patients with 3L+ R/R DLBCL still face a poor prognosis – particularly those who do not receive, or relapse after, SCT or CAR-T therapy.1-4 There are many burdens and barriers to successful treatment at this stage. These include:
- Disease related - such as disease that is primary refractory or has high-risk characteristics like double- or triple-hit DLBCL3,5,6
- Treatment related - for instance declining efficacy of chemotherapy-based regimens with each line of treatment and CAR-T being ineligible for some patients1,2,4,6,7
- Patient-related - those who live far from expert centres or who lack family or social support may struggle to access treatment1,2,7
These barriers mean patients may not respond to, or be eligible for, treatments for 3L+ R/R DLBCL.
ZYNLONTA as a monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and high grade B-cell lymphoma after two or more lines of systemic therapy.8
The National Institute for Health and Care Excellence (NICE) has recommended ZYNLONTA as an option for treating relapsed or refractory DLBCL and HGBL after 2 or more systemic treatments in adults if they have previously had polatuzamab vedotin or if it is contraindicated or not tolerated.9
The Scottish Medicines Consortium (SMC) has recommended ZYNLONTA as monotherapy for the treatment of adult patients with relapsed or refractory DLBCL and HGBL, after 2 or more lines of systemic therapy.
SMC restriction: where CAR-T-cell therapy is unsuitable, not tolerated or ineffective.
This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.
ZYNLONTA is a potent, single-agent CD19 targeted antibody-drug conjugate therapy.8,10,11 ZYNLONTA binds with high affinity to the CD19 antigen on the tumour cell surface. ZYNLONTA is rapidly internalised into the cell and only then is the cytotoxic payload released.11,12 This cytotoxic, PBD, binds. DNA, stopping the tumour cell's replication and leading to apoptosis.11,12 This second-generation ADC design and MoA of ZYNLONTA leads to efficacy in patients with undetectable or low levels of CD19 expression.11,13
ZYNLONTA prescribing information
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (for United Kingdom) and www.hpra.ie (for Republic of Ireland). Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754.
Abbreviations:
ADC, antibody-drug conjugate; CR, complete response; 3L r/r DLBCL, third-line relapsed/refractory diffuse large B-cell lymphoma; HGBL, high grade B-cell lymphoma; SmPC, summary of product characteristics; MoA, mechanism of action; CAR-T, chimeric antigen receptor T-cell, mDOR. median duration of response; CR, complete response; TEAES, treatment-emergent adverse events
References:
1. Klink AJ et al. J Clin Pathways 2020; 6: 44-53. 2. Sermer D et al. Blood Adv 2020; 4: 4669-4678. 3. Khelfa Y et al. Curr Oncol Rep 2017; 19: 74. 4. Schuster SJ et al. N Engl J Med 2019; 380: 45-56. 5. Sarkozy C, Lehn LH. Best Practice & Research Haematology 2018; 31: 209-216. 6. Galaznik A et al. Future Sci OA 2018; 4: 322. 7. Jommi C et al. Front Pharmacol 2022; 13: 915342. 8. ZYNLONTA SmPC, GB. 9. National Institute for Health and Care Excellence. Technology Appraisal Guide TA947 (nice.org.uk). Last accessed September 2024. 10. Zammarchi F et al. Blood 2018; 131: 1094- 1105. 11. Caimi PF et al. Lancet Oncol 2021; 22: 790-800. 12. Hartley JA. Expert Opin Biol Ther 2021; 21: 931-943. 13. Caimi PF et al. Poster presented at 64th Annual Society of Hematology meeting, Dec 10-13th, 2022, New Orleans, USA.
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