Elzonris(tagraxofusp)

Oncology· 142 cited findings· 1 source document

Company: Stemline B V

What the regulatory reviews say

Elzonris (tagraxofusp) is a drug designated as an orphan medicinal product on 11 November 2015 (EU/3/15/1567). The application for its use was submitted on 7 January 2019, with a re-examination request on 5 August 2020, and a final opinion from CHMP on 12 November 2020. The recommended Phase 2 Dose (RP2D) of tagraxofusp for BPDCN is 12 μg/kg.

Efficacy findings include a complete response rate of 86% with CHOP-like regimens and 90% with hyper-CVAD. The median duration of response for hyper-CVAD was 20 months, with a median overall survival of 29 months. For AML-like regimens, the complete response rate was 83%. The median overall survival was 58 ± 2 days, compared to 17 days for control. The complete response rate (CR/CRc) was 53.8%.

Safety data, assessed by CHMP for 239 patients, indicated 0 deaths due to CLS. Deaths within 30 days of the last dose were 11%. Treatment-related mortality for intensive chemotherapy ranged from 17% to 26%. The median duration of exposure to tagraxofusp was 96 days for first-line BPDCN and 48 days for R/R BPDCN.

Key figures — cited to the source page

Complete response rate (CHOP-like regimens)	86%	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.12
Complete response rate (hyper-CVAD)	90%	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.12
Median overall survival (hyper-CVAD)	29 months	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.12
Median overall survival	58 ± 2 days	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.25
Median overall survival (control)	17 days	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.25
Deaths within 30 days of last dose	11%	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.193
Treatment-related mortality for intensive chemotherapy	17% to 26%	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.194
Orphan medicinal product designation date	11 November 2015	Stemline B V — Elzonris EMA EPAR public assessment report (E, p.7

Source documents

Stemline B V — Elzonris EMA EPAR public assessment report (EMEA/H/C/005031, 2021) (2021)

Explore the full evidence

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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.