marked.bio

ROS1 TKI (brain-penetrant) · small molecule

zidesamtinib

1 active trials, targeting ROS1. 1 active approval for a biomarker on marked.bio.

Also known as NVL-520, Jideytro.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
zidesamtinib
FDA, 2026
locally advanced or metastatic ROS1-positive, after >=1 prior ROS1 TKI FDA approval 22/07/2026 (announced as an approval, not accelerated). No EU application found. Source
Jideytro 		ROS1 fusion NSCLC Approved 2026 Not approved

ARROS-1 single-arm, 117 patients
Response 44% (34-53)Lasting 69% still responding at 12 months

Trial details and side effects
Patients
ROS1-positive NSCLC after at least one ROS1 TKI (NCT05118789)
Most common side effects
oedema, peripheral neuropathy, constipation, fatigue, dyspnoea
Notes
From the FDA approval report; the label's side-effect percentages are not yet in our data.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
ROS1 fusion 1 1 Phase 1/2

Sponsors

Industry sponsors leading active biomarker-selected trials of zidesamtinib.

  1. Nuvalent 1

Trials

1 of 1 trials shown

  1. A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

    Recruiting Phase 1/2 Nuvalent Started 2022Primary completion 2027-12 NCT05118789

    zidesamtinib FDA

    …lly or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.

    ROS1 fusionLocally Advanced Solid Tumor, Metastatic Solid Tumor