Zynlonta

Oncology· 381 cited findings· 1 source document

Company: Swedish Orphan Biovitrum

What the regulatory reviews say

Zynlonta is indicated as monotherapy 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. The application for marketing authorisation was submitted on 6 October 2021, and a positive opinion from the CHMP was issued on 15 September 2022. Zynlonta has been granted orphan medicinal product designation EU/3/21/2481.

In terms of efficacy, the objective response rate (ORR) was 21.2%. The median overall survival was approximately 6 months. For safety, the median treatment duration was 45.0 days, with a median of 3.0 treatment cycles. 212% of patients experienced any treatment-emergent adverse event (TEAE), and 160% experienced any Grade 3 or higher TEAE. 176% of patients had TEAEs related to ADCT-402.

Key figures — cited to the source page

Approved indication	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.	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.2
Objective response rate (ORR)	21.2%	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.13
Median overall survival	approximately 6 months	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.13
Patients with any TEAE	212%	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.106
Patients with any Grade 3 or higher TEAE	160%	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.107
Patients with any TEAE related to ADCT-402	176%	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.107
Application for marketing authorisation submission date	6 October 2021	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.7
CHMP positive opinion date	15 September 2022	Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessme, p.9

Source documents

Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessment report (EMEA/H/C/005685, 2022) (2022)

Explore the full evidence

All 381 cited findings for Zynlonta — searchable, comparable and answerable in plain language — are in the Oncology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.