FDA drug record/Cancer/Jideytro

FDA record · Cancer

Jideytro (zidesamtinib)

What FDA's own documents say about Jideytro: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.

Sponsor
Nuvalent
Application
NDA 220185
First approved
July 22, 2026
Status
Approved
Read from
11 FDA documents, 447 pages

What it is approved for

“JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.”

Prescribing Information (Label) · PDF p. 2 · fda.gov ↗

Trials FDA reviewed

TrialClinicalTrials.govPhaseMentionsDocuments
NVL-520not given2125 of 11
ARROS-1NVL-520-01NCT051187891/21338 of 11

Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.

Safety

Most common adverse reactions

“Most common adverse reactions (>=15%) were: edema, peripheral neuropathy, constipation, fatigue, and dyspnea.”

Prescribing Information (Label) · PDF p. 2 · fda.gov ↗

Adverse events the documents discuss most

Dosing on the label

“Recommended Dosage: 100 mg orally once daily with or without food until disease progression or unacceptable toxicity.”

Prescribing Information (Label) · PDF p. 2 · fda.gov ↗

FDA documents read

DocumentDatePagesCopysha256
Approval letter220185Orig1s000ltr.pdfJuly 24, 20269d3196ef5a3f5
Prescribing information, original approval220185s000lbl.pdfJuly 27, 202617e8fa978689a1
Administrative Correspondence220185Orig1s000AdminCorres.pdfAugust 24, 202634c19bfbb9559a
Approval Letter220185Orig1s000Approv.pdfAugust 24, 2026124655c6cb6c64
Chemistry Review220185Orig1s000ChemR.pdfAugust 24, 2026325960a75a083b
Prescribing Information (Label)220185Orig1s000Lbl.pdfAugust 24, 2026192d4ae5dc97ab
Multi-disciplinary Review220185Orig1s000MultidisciplineR.pdfAugust 24, 202623507ec2ebfd638
Proprietary Name Review220185Orig1s000NameR.pdfAugust 24, 2026257177b1978568
Officer/Employee List220185Orig1s000OEList.pdfAugust 24, 202636a1d31dfaa25
Other Reviews220185Orig1s000OtherR.pdfAugust 24, 2026479f9c9709bb87
Risk Assessment / REMS Review220185Orig1s000RiskR.pdfAugust 24, 2026140ecc6566632f

Checked against FDA's copies on September 29, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.

Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.

Every drug for Cancer · All disease areas