Zynlonta

loncastuximab tesirine

Table of contents

Opinion

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Zynlonta2, intended for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL). The applicant for this medicinal product is ADC Therapeutics (NL) B.V.

Zynlonta will be available as a 10 mg powder for concentrate for solution for infusion. The active substance of Zynlonta is loncastuximab tesirine, a monoclonal antibody and drug conjugate (ATC code: L01FX22). Zynlonta delivers SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin, to B-cell malignancies by targeting CD19. Upon binding to CD19, Zynlonta is internalised and SG3199 is released, resulting in the formation of highly cytotoxic DNA interstrand cross-links, which cause cell-death.

The benefits of Zynlonta are its ability to provide durable treatment responses after up to 1 year of treatment in patients with relapsed or refractory DLBCL, as shown in a phase 2, open-label, single arm study. The most common side effects are gamma-glutamyltransferase (GGT) increased, neutropenia, fatigue, anaemia, thrombocytopenia, nausea, peripheral oedema and rash.

The full indication is:

Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

Zynlonta should be prescribed by physicians experienced in the treatment of cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.

2This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

Key facts

Name
Zynlonta
Agency product number
EMEA/H/C/005685
International non-proprietary name (INN) or common name
  • loncastuximab tesirine
Active substance
  • loncastuximab tesirine
Therapeutic area
Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
15/09/2022
Company name
ADC Therapeutics (NL) B.V
Status
Positive
Application type
Initial authorisation

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