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A ROS1 inhibitor approved in July 2026 that works after other ROS1 drugs fail and avoids their brain side effects.
Zidesamtinib is a ROS1-selective tyrosine kinase inhibitor engineered to spare TRK and penetrate the brain, so it avoids the dizziness and weight gain caused by the TRK activity of repotrectinib and entrectinib while covering the G2032R resistance mutation. It is Nuvalent's first approved drug, cleared in July 2026 for ROS1-positive NSCLC on the ARROS-1 trial, and it is taken once daily. Oedema, fatigue, constipation and raised ALT are the main adverse events reported. It is intended both for patients whose disease has progressed on earlier ROS1 inhibitors and as a better-tolerated option, though its first-line position against repotrectinib and the durability of response are still being defined. Nuvalent's ALK inhibitor neladalkib follows the same selective design. For a newcomer: a ROS1 pill built to work after others fail without the brain side effects.
TRK-sparing, brain-penetrant ROS1-selective TKI.
1.Oral drug is absorbed and reaches the tumour
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Sources: NICE search: zidesamtinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
PDUFA target action date stated by Nuvalent when the FDA accepted the new drug application. Nuvalent's first potential approval. Source
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Breakthrough Therapy designation, ROS1+ NSCLC after prior ROS1 TKI source
ROS1+ NSCLC after at least one prior ROS1 TKI (ARROS-1) source
| 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.
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Query 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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