Zidesamtinib
A ROS1 inhibitor approved in July 2026 that works after other ROS1 drugs fail and avoids their brain side effects.
Nuvalent's first approval (ARROS-1). Designed to spare TRK (avoiding dizziness and weight gain of repotrectinib/entrectinib) while covering the G2032R resistance mutation. Nuvalent's ALK inhibitor neladalkib follows.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- Once daily (label dose per July 2026 approval)
- Monitoring
- LFTs, oedema, neuro-cognitive symptoms (minimised by TRK sparing)
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: zidesamtinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Jun 2024DesignationUS
Breakthrough Therapy designation, ROS1+ NSCLC after prior ROS1 TKI source
- Jul 2026ApprovalUS
ROS1+ NSCLC (ARROS-1) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | ROS1+ NSCLC (July 2026) |
| Adverse event |
|---|
| Oedema |
| Fatigue |
| Constipation |
| ALT increased |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Zidesamtinib" OR ABSTRACT:"Zidesamtinib" OR TITLE:"Jideytro" OR ABSTRACT:"Jideytro") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Zidesamtinib, not a curated reading list.
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