New Pill for a Rare Gene-Related Lung Cancer

Jideytro (zidesamtinib; Patient Information pronunciation jih-DAY-troh) is an oral kinase inhibitor that inhibits ROS1, including certain ROS1 resistance mutations. In laboratory assays it also shows inhibitory effects on ALK and TRK family kinases — those are pharmacology facts on the USPI, not separate labelled indications. It is given as a tablet, with or without food, swallowed whole.

The FDA approved NDA 220185 on 22 July 2026 (Novel Drug Approvals for 2026 table row 27 on the scan spine used for this draft). Approval letter signed R. Angelo de Claro, M.D. (Romeo A. de Claro), Director, Office of Oncologic Diseases, OND/CDER (electronic signature 22 Jul 2026 11:12:42). NDA received 19 September 2025. Applicant / distributed by on the USPI: Nuvalent, Inc., Cambridge, MA. Expiry dating (approval letter): 30 months from manufacture at controlled room temperature. The application was not referred to an FDA advisory committee. FDA oncology notice: review used Real-Time Oncology Review (RTOR) and the Assessment Aid; approval came about two months ahead of the goal date. Designations cited on FDA / company materials: Orphan Drug; GSK press also cites Breakthrough Therapy. FDA notice wording uses “at least one prior ROS1 tyrosine kinase inhibitor”; the USPI indication is adults who received a prior ROS1 kinase inhibitor — use the label for the prescription conversation.

GSK / Nuvalent framing (company): GSK plc announced on 15 July 2026 that it completed acquisition of Nuvalent, Inc. GSK’s 22 July 2026 approval press describes Jideytro as part of the portfolio from that recently completed acquisition, and as GSK’s first approved medicine in lung cancer. The USPI and approval letter still name Nuvalent, Inc. as distributor / NDA applicant. Fact-only: commercial ownership story is GSK acquisition of Nuvalent; labelled supply contacts on the USPI remain the Nuvalent phone / site until a later label revision says otherwise.

Distinct from other ROS1 TKIs: Prior agents named on the ARROS-1 label narrative include crizotinib, entrectinib, repotrectinib, taletrectinib, and lorlatinib. Jideytro is a separate labelled product with its own dose, safety story (CNS effects, QTc, ILD/pneumonitis, fractures, CPK/myalgia, pancreatic labs, embryo-fetal toxicity), and post–prior-TKI indication. Compare labels with the clinic; they are not interchangeable.

Where this is taking place

Commercial labelled door today: United States — FDA full approval for adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor. A thoracic oncologist or ROS1-capable clinic confirms ROS1 fusion status, prior TKI history, baseline labs/ECG, and writes the labelled oral course. Prior authorization and plan coverage still apply. Authorized ≠ funded.

ARROS-1 — NCT05118789 (USPI Study) — Phase 1/2, multicenter, single-arm, open-label, multi-cohort. Sponsor on ClinicalTrials.gov: Nuvalent Inc. Status retrieved for this draft: RECRUITING. Estimated enrolment 359. Start 4 Jan 2022; estimated primary completion 31 Dec 2027; estimated study completion 31 Dec 2028. Study Director on the CT.gov record: Vivek Upadhyay, MD, MBI (Nuvalent Inc.). Central contact on the record: Nuvalent — 857-357-7000 / clinicaltrials@nuvalent.com (trial operations — not a commercial prescription desk). Site countries on the record include United States, Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan, and the United Kingdom. US facilities named on the API sample include (among others) Memorial Sloan Kettering Cancer Center, Dana-Farber, Mass General, Stanford, UCLA/UCI/UC Davis, University of Colorado, NYU Langone, Washington University, and others. Canadian sites on the record: Cross Cancer Institute (Edmonton); Princess Margaret Cancer Research (Toronto). GSK company materials: zidesamtinib continues to be studied in ARROS-1, including in first-line patients who have not previously received a ROS1 inhibitor — that TKI-naive / other-tumour work is not the US commercial labelled indication. A recruiting trial is not the same door as a labelled US prescription for pretreated adults. Trial geography ≠ a national licence outside the US.

Outside the United States: As of this draft, no confirmed Health Canada Notice of Compliance, European Commission marketing authorisation, MHRA licence, TGA ARTG listing, Swissmedic authorisation, NMPA decision, or PMDA/MHLW licence for Jideytro / zidesamtinib. Do not import on your own.

The practical door in the US is a lung-cancer clinician who can confirm ROS1-positive disease, prior ROS1 TKI exposure, order baseline CPK / ECG / electrolytes / lipase / amylase, manage CNS / QTc / ILD watch, and write labelled 100 mg once daily — not a mail-order bottle from a press headline.

Approval matrix

Access by country

• United States: Ask a thoracic / medical oncology clinic about FDA-labelled Jideytro. Labelled 22 July 2026 for adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor. Dose: 100 mg orally once daily with or without food; swallow whole; continue until progression or unacceptable toxicity. Dose reductions for adverse reactions: first 75 mg once daily, then 50 mg once daily; permanently discontinue if unable to tolerate 50 mg. Before start: CPK, ECG, electrolytes, lipase, amylase. No list price or copay dollars in this article. Prior authorization still applies. USPI adverse-reaction contact: Nuvalent 1-844-NUVL-111 (1-844-688-5111); www.JIDEYTRO.com; FDA MedWatch 1-800-FDA-1088. Prescribing Information: FDA label PDF / Nuvalent FPI host. This is US commercial labelled supply, not Special Access and not a DIY import.

• Canada: Authorisation not confirmed. ARROS-1 lists Canadian sites — that is research geography, not a Product Monograph. Do not assume SAP, named-patient, or cross-border mail-order is available or appropriate. Ask the Canadian ROS1 / thoracic clinic what legal paths exist in Canada when a Jideytro Canadian label does not yet exist.

• European Union / United Kingdom / Australia / Japan / other countries with ARROS-1 sites: Trial participation ≠ commercial Jideytro label. Regulator authorisation not confirmed in this draft.

• If your regulator has not authorised it: do not import on your own. Ask the local oncology clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or open ARROS-1 cohorts that actually match eligibility (for example TKI-naive first-line research) — without treating a US bottle as a foreign carton.

Who is eligible (from the US label)

This is an adult, post–prior ROS1 TKI conversation on the USPI — not a first-line labelled indication and not a paediatric label.

United States (USPI / Patient Information, revised / issued July 2026):

• Indication: Treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor.
• Dose: 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
• Swallow whole. Do not split, chew, crush, or dissolve.
• Missed dose: if missed within 12 hours of the scheduled time, take as soon as possible; if missed by 12 hours or more, take the next dose at the scheduled time. Do not double.
• Vomiting: take the next dose at the scheduled time.
• Before initiating: evaluate CPK, ECG, electrolytes, lipase, and amylase.
• Contraindications: None on the USPI.
• Pregnancy / contraception: Can cause fetal harm. Verify pregnancy status before start when applicable. Females of reproductive potential: effective contraception during treatment and for 6 months after the last dose. Males with female partners of reproductive potential: effective contraception during treatment and for 3 months after the last dose.
• Lactation: Advise not to breastfeed during treatment and for 1 week after the last dose.
• Fertility: May impair fertility in males and females (animal data); male findings described as reversible; female reversibility unknown on the label.
• Pediatrics: Safety and effectiveness not established.
• Geriatrics: Of 446 pooled patients, 22% were 65–74 and 8% were ≥75; no clinically meaningful safety/efficacy differences vs younger adults described on the label.
• Renal: No dosage modification recommended for eGFR 30–90 mL/min; effect of severe renal impairment (eGFR <30) or dialysis unknown.
• Hepatic: No dosage modification recommended for mild or moderate hepatic impairment; effect of severe hepatic impairment unknown.
• ARROS-1 efficacy population narrative (USPI): median age 57 (31–83); 56% female; 68% never smoked; 100% metastatic; 49% CNS metastases by BICR; 50% one prior ROS1 TKI / 50% two or more (including lorlatinib, repotrectinib and/or taletrectinib in 93% of the ≥2-TKI group).

Not labelled on sources confirmed for this draft:

• First-line / ROS1 TKI–naive commercial use (ARROS-1 first-line research continues — not the US commercial indication).
• Children / adolescents.
• EU, UK, Canadian, Japanese, Australian, Swiss, or Chinese Jideytro marketing authorisations (not confirmed here).
• Replacing another ROS1 TKI by self-switching without a clinician reading both labels.

What the pivotal study showed (ARROS-1 / USPI)

Use the USPI for a US prescription conversation. Journals and conference abstracts are supportive reading.

ARROS-1 — NCT05118789:

• Multicenter, single-arm, open-label, multi-cohort; efficacy population for the label: 117 patients with previously treated locally advanced or metastatic ROS1-positive NSCLC who received Jideytro 100 mg once daily.
• Eligible patients: ROS1-positive disease, ECOG ≤1, measurable disease per RECIST v1.1; asymptomatic stable intracranial metastases allowed. ROS1 fusions identified locally by NGS, PCR, or FISH.
• Major efficacy outcomes: confirmed ORR and DOR by BICR (RECIST v1.1); intracranial response by modified RECIST v1.1 / BICR.

USPI Table 5 (ROS1 TKI–pretreated, N=117, BICR):

• One prior ROS1 TKI (N=59): ORR 49% (95% CI: 36, 63).
• Two or more prior ROS1 TKIs (N=58): ORR 38% (95% CI: 26, 52).
• Measurable CNS metastases at baseline without brain radiation within 2 months (N=50): intracranial responses in 48% (95% CI: 34, 63), including 22% complete responses.
• Responses observed in 21/42 (50%) patients with ROS1 resistance mutations, including 14/26 (54%) with G2032R.

Trial-status honesty: The pretreated efficacy cohort supports the US label. CT.gov remains RECRUITING because other cohorts (including first-line research per company materials) continue — that is not a substitute for labelled commercial use in pretreated adults, and not a licence outside the US. FDA PMC 5032-5 requires further characterization of ORR/DOR with longer DOR follow-up in the same 117-patient pretreated set.

How it is taken (US label — keep this exact)

Safety (USPI)

Contraindications: None.

Warnings and precautions:

• CNS adverse reactions (dizziness, ataxia, cognitive and psychiatric disorders) — 25% pooled (Grade 3/4 2.5%). Avoid hazardous tasks (driving / machinery) if CNS symptoms are present. Monitor for suicidal thoughts/behaviors.
• QTc interval prolongation — evaluate ECG and electrolytes before and periodically; watch concomitant QT-prolonging drugs.
• ILD / pneumonitis — 1.8% pooled (Grade 3/4 0.4%); withhold for new/worsening pulmonary symptoms.
• Skeletal fractures — 1.1% pooled; report fracture symptoms.
• Myalgia with CPK elevation — monitor CPK at baseline, every 2 weeks in month 1, then every 1–2 months / as indicated; report unexplained muscle pain.
• Pancreatic toxicity — amylase/lipase monitoring; Grade 3 pancreatitis in 0.2% pooled.
• Embryo-fetal toxicity — contraception windows as above.

Most common adverse reactions (≥15% pooled safety, N=446): edema 38%, peripheral neuropathy 25%, constipation 17%, fatigue 16%, dyspnea 15%.

ARROS-1 ROS1-positive NSCLC safety set (N=432, USPI Table 3 ≥10% all grades — selected): edema 38%; peripheral neuropathy 25%; constipation 17%; fatigue 16%; dysgeusia 15%; dyspnea 15%; cough 13%; myalgia 13%; dizziness 12%; headache 12%; rash 12%; vision disorders 12%; diarrhea 11%; arthralgia 11%; pneumonia 11% (Grade 3/4 pneumonia 6%). Serious ARs 22% (pneumonia 6%, dyspnea 2.5%). Permanent discontinuation for AR 2.3%. Dose interruption 30%; dose reduction 10%.

Drug interactions (high level): Avoid strong and moderate CYP3A inhibitors; avoid strong and moderate CYP3A inducers.

Report suspected adverse reactions to Nuvalent 1-844-688-5111 or FDA MedWatch 1-800-FDA-1088.

No boxed warning on the USPI retrieved for this draft. That is not “no risk” — CNS effects, QTc, ILD, fractures, CPK/myalgia, pancreatic labs, and pregnancy are the main labelled safety story.

Research team (source-only)

Names and roles as they appear on primary sources — not a clinic directory.

• Nuvalent, Inc., Cambridge, MA — NDA 220185 applicant; USPI distributor; ARROS-1 sponsor; Patient Information / AE contact 1-844-688-5111 / www.JIDEYTRO.com.
• GSK plc — company approval press (22 Jul 2026); completed acquisition of Nuvalent (15 Jul 2026 press). Commercial portfolio framing — not a substitute for the USPI distributor line until the label changes.
• Virginia Vetter — Vice President, Global Regulatory Affairs, Nuvalent; addressee on the NDA approval letter (corporate regulatory contact, not a treating clinic).
• R. Angelo de Claro, M.D. — Director, Office of Oncologic Diseases, OND/CDER — signed the 22 Jul 2026 approval letter.
• Raniya Al-Matari — FDA Regulatory Health Project Manager named on the approval letter (agency contact, not a patient hotline).
• Vivek Upadhyay, MD, MBI — Study Director, Nuvalent Inc., on the NCT05118789 CT.gov record.
• Alexander Drilon, MD — ARROS-1 trial investigator; Chief of the Early Development Service, Memorial Sloan Kettering Cancer Center — quoted on the GSK 22 Jul 2026 approval press (investigator quote, not a national referral desk). Press note: has served as consultant to and/or received expense reimbursements from Nuvalent.
• Janet Freeman-Daily — Co-Founder and President, The ROS1ders — quoted on the GSK approval press (patient-community voice, not a prescribing contact).
• Tony Wood — Chief Scientific Officer, GSK — quoted on the approval press (company leadership, not a clinic).
• CT.gov trial contact: clinicaltrials@nuvalent.com / 857-357-7000 — trial information, not commercial fill.

Site-level hospital phone numbers are not listed here — ask your own oncology clinician.

How to talk to a doctor

Bring the brand, the INN, the NCT number, and the US label:

1. “I have locally advanced or metastatic ROS1-positive NSCLC and I have already been on a ROS1 kinase inhibitor. The FDA labelled Jideytro (zidesamtinib) on 22 July 2026. Is that a fit for me in this country?”
2. “The labelled dose is 100 mg by mouth once daily with or without food. What baseline tests (CPK, ECG, electrolytes, lipase/amylase) and monitoring do we need?”
3. “ARROS-1 (NCT05118789) showed a 44% confirmed ORR by BICR in 117 TKI-pretreated patients, with 82% of responders lasting ≥6 months and 69% ≥12 months. Can we read the CNS and resistance-mutation subgroups on the USPI together?”
4. “I have / have not had brain metastases, QT issues, lung inflammation, fractures, or muscle pain. I do / do not take strong CYP3A inhibitors or inducers.”
5. “Side effects to watch: swelling, nerve symptoms, constipation, fatigue, shortness of breath, dizziness/thinking changes, and new cough or fever. When should I call?”
6. “I understand this is labelled after a prior ROS1 TKI — not a first-line commercial label on the USPI.”
7. If outside the US: “Is there a licence in this country yet? I will not mail-order a US bottle.”
8. “Prior authorization — what does my plan need (ROS1 report, prior TKI names, staging)?”

Canada zoom: authorisation not confirmed

There is no retrieved Health Canada Notice of Compliance or DIN for Jideytro / zidesamtinib on the sources used for this draft. US FDA approval does not create a Canadian Product Monograph. ARROS-1 lists Canadian research sites — that is not Canadian marketing authorisation. Do not treat cross-border mail-order as the care plan. Ask a Canadian thoracic / ROS1 clinician what legal options exist while waiting for any future Canadian decision.

Bottom line

Jideytro (zidesamtinib) is an FDA-approved oral ROS1 kinase inhibitor — labelled 22 July 2026 (NDA 220185) for adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor. Dose is 100 mg by mouth once daily until progression or unacceptable toxicity. ARROS-1 (NCT05118789) showed 44% BICR ORR in 117 TKI-pretreated patients, with durable responses in many responders and activity described in CNS and resistance-mutation subgroups on the label. Main safety watch: CNS effects, QTc, ILD/pneumonitis, fractures, CPK/myalgia, pancreatic labs, and pregnancy. US primary; other regulators not confirmed. Nuvalent is the USPI distributor; GSK describes commercial ownership via completed Nuvalent acquisition. The practical door is a US oncology clinician and a labelled prescription — a recruiting ARROS-1 cohort is not the same as the commercial pretreated label, and a US bottle is not another country’s carton. Authorized is not funded.

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Primary sources

1. FDA — FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer (notice; RTOR, Assessment Aid, Orphan Drug; dose 100 mg once daily) — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer
2. FDA Prescribing Information PDF, NDA 220185, label 220185s000lbl.pdf, Revised 7/2026 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220185s000lbl.pdf
3. FDA NDA approval letter, NDA 220185, signed R. Angelo de Claro, M.D., 22 Jul 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220185Orig1s000ltr.pdf
4. FDA Novel Drug Approvals for 2026 — Jideytro / zidesamtinib / 7/22/2026 (row 27 on scan spine) — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
5. GSK press release — Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive NSCLC, 22 Jul 2026 — https://www.gsk.com/en-gb/media/press-releases/jideytro-zidesamtinib-approved-in-the-us-for-previously-treated-ros1-positive-non-small-cell-lung-cancer/
6. GSK press release — GSK completes acquisition of Nuvalent, Inc., 15 Jul 2026 — https://www.gsk.com/en-gb/media/press-releases/gsk-completes-acquisition-of-nuvalent-inc/
7. Nuvalent Full Prescribing Information host (company FPI PDF) — https://nuvalent.com/pdfs/jideytro-full-prescribing-information.pdf
8. ClinicalTrials.gov ARROS-1 NCT05118789 — https://clinicaltrials.gov/study/NCT05118789
9. Nuvalent press (NDA acceptance context, 19 Nov 2025) — cited from GSK approval-press reference list — https://investors.nuvalent.com/2025-11-19-Nuvalent-Announces-FDA-Acceptance-of-New-Drug-Application-for-Zidesamtinib-for-the-Treatment-of-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC