Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer

Rhea-AI Summary

GSK (NYSE:GSK) announced that the US FDA has approved Jideytro (zidesamtinib), a ROS1-selective kinase inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor. The approval, granted ahead of the original 18 September 2026 target action date, follows Breakthrough Therapy and Orphan Drug Designations.

According to GSK, approval is based on the single-arm phase I/II ARROS-1 trial (n=117), which showed a 44% objective response rate and 6- and 12‑month duration-of-response rates of 82% and 69%. In the pooled safety population (n=446), common adverse reactions (≥15%) included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea. Jideytro is GSK's first approved lung cancer medicine and part of the portfolio acquired with Nuvalent, alongside additional lung cancer assets in development.

Positive

• FDA approval of Jideytro for previously treated ROS1-positive NSCLC in US adults
• Regulatory decision ahead of target date before 18 September 2026 PDUFA goal
• ARROS-1 efficacy: 44% objective response rate in 117 previously ROS1 inhibitor-treated patients
• Durable responses: 6- and 12-month DOR rates of 82% and 69%
• First GSK lung cancer approval, expanding its oncology portfolio into NSCLC
• Leverages Nuvalent acquisition, validating recently acquired targeted oncology assets

Negative

• Common adverse reactions (≥15%) include oedema, peripheral neuropathy, constipation, fatigue and dyspnoea

News Explained

GSK’s remaining lung-cancer pipeline is at different stages: neladalkib is under FDA review with a target decision date of November 27, 2026, while NVL-330 remains investigational.

News Market Reaction – GSK

-0.04%

-0.04% Session close to close

In the Jul 22 session, GSK declined 0.04%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

GSK's prior real-world vaccine-data event recorded a 0.51% 24-hour reaction, adding historical conte...

Analysis

GSK's prior real-world vaccine-data event recorded a 0.51% 24-hour reaction, adding historical context to this approval. The low short-positioning level is a separate risk indicator; investors can watch subsequent regulatory and commercial disclosures.

Key Figures

Original target action date: 18 September 2026 Annual ROS1-positive NSCLC diagnoses: Approximately 50,000 people Overall population: n=117 +5 more

8 metrics

Original target action date 18 September 2026 FDA approval came ahead of the target date

Annual ROS1-positive NSCLC diagnoses Approximately 50,000 people Worldwide annual diagnoses

Overall population n=117 ARROS-1 phase I/II trial

Objective response rate 44% ARROS-1 overall population; 95% CI: 34-53%

Confidence interval 95% CI: 34-53% Objective response rate estimate

Duration of response at six months 82% ARROS-1 trial

Duration of response at 12 months 69% ARROS-1 trial

Pooled safety population n=446 Common adverse reactions assessed in the pooled safety population

Historical Context

4 past events · Latest: May 07 (Neutral)

Pattern 4 events

Date	Event	Sentiment	24h Move	Catalyst
May 07	Disease awareness campaign	Neutral	-0.1%	Meningitis awareness campaign highlighted risks and vaccination discussions
Mar 13	Vaccine indication expansion	Positive	-1.6%	FDA expanded AREXVY approval to higher-risk adults aged 18–49
Feb 23	Manufacturing contract renewal	Positive	-0.4%	Bora renewed GSK's five-year global manufacturing agreement through 2030
Feb 18	Real-world vaccine data	Positive	+0.5%	AREXVY data showed associations with reduced RSV-related hospitalization risks

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

GSK's recent favorable healthcare and corporate announcements more often diverged from positive price reactions than aligned with them.

Key Terms

ros1 selective inhibitor, non-small cell lung cancer, objective response rate, duration of response, +1 more

5 terms

ros1 selective inhibitor medical

"Jideytro (zidesamtinib), a ROS1 selective inhibitor"

A ROS1 selective inhibitor is a type of targeted cancer drug that blocks the activity of the ROS1 protein, which can be abnormally active when fused with other genes and drive tumor growth. Like a key that fits a specific lock, these drugs are designed to shut down a specific molecular driver in tumors identified by a lab test; that specificity matters to investors because it shapes the drug’s potential market size, regulatory path, and reliance on diagnostic testing and trial results.

non-small cell lung cancer medical

"ROS1-positive non-small cell lung cancer (NSCLC)"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

objective response rate medical

"the objective response rate (ORR) was 44%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

duration of response medical

"Duration of response (DOR) rates at six and 12 months"

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

blood-brain barrier penetration medical

"and blood-brain barrier penetration to address disease in the brain"

The ability of a drug or molecule to cross the blood-brain barrier and reach tissue inside the brain. It matters to investors because crossing this tightly controlled biological “security gate” affects whether a medicine can treat neurological or psychiatric conditions, influences dosing, safety risks, development complexity and regulatory review, and therefore can change the potential commercial value and timeline of a drug program.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Approval based on ARROS-1 phase I/II trial demonstrating meaningful and durable responses in patients with locally advanced or metastatic disease¹
• Next-generation design aims to address key efficacy and tolerability challenges of treating ROS1-positive NSCLC
• GSK's first approval in lung cancer, part of a growing portfolio of targeted treatments

LONDON, July 22, 2026 /PRNewswire/ -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, 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.¹ The approval comes ahead of the original target action date of 18 September 2026 and follows the FDA's Breakthrough Therapy and Orphan Drug Designations.²

Jideytro, part of the portfolio from the recently completed acquisition of Nuvalent, Inc.³, was developed to address key efficacy and/or tolerability challenges of treating ROS1-postive NSCLC. Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration to address disease in the brain. Approximately 50,000 people worldwide are diagnosed each year with ROS1-positive NSCLC, often non-smokers in their 40s and 50s who could stay on treatment for several years.^4,5

Tony Wood, Chief Scientific Officer, GSK, said: "The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer. Today's approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care."

The approval of Jideytro is based on results from the global single-arm ARROS-1 phase I/II clinical trial in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall population (n=117), the objective response rate (ORR) was 44% (95% confidence interval [CI]: 34-53%). Duration of response (DOR) rates at six and 12 months were 82% and 69%, respectively.¹

The most common (≥15%) adverse reactions in the pooled safety population (n=446) included: oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.¹

Alexander Drilon, MD, ARROS-1 trial investigator and Chief of the Early Development Service at Memorial Sloan Kettering Cancer Center, said: "Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients. The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease."

Janet Freeman-Daily, Co-Founder and President of The ROS1ders, said: "For patients, the goal is not just more time, but quality time to live life as normally as possible while on treatment. The ROS1-positive community is deeply invested in advancing care with treatments that are effective and tolerable. Today's approval gives patients and their doctors an important new option and represents meaningful progress for our community."

Jideytro is GSK's first approved medicine in lung cancer. The company is advancing additional medicines from the recent Nuvalent acquisition, including neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review with a target decision date of 27 November 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC. GSK is also advancing risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate in late-stage development with recently reported positive phase III data⁶ in relapsed small-cell lung cancer from licensor Hansoh Pharma Inc.

About Jideytro
Jideytro is a kinase inhibitor that is FDA approved 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.

Jideytro was designed as a ROS1 selective inhibitor with broad coverage of ROS1 resistance mutations, activity against disease that has spread to the brain, durable treatment responses and a tolerable profile. Together, these features aim to help patients maintain disease control for longer while reducing the treatment challenges that can emerge over time.

The US Prescribing Information will be available here⁷.

About the ARROS-1 trial
ARROS-1 (NCT05118789) is a global phase I/II trial evaluating zidesamtinib in patients with advanced ROS1-positive NSCLC and other ROS1-positive solid tumours.⁸ The FDA approval is based on results from 117 patients with ROS1-positive NSCLC previously treated with a ROS1 inhibitor.¹

Zidesamtinib continues to be studied in ARROS-1, including in first-line treatment for patients who have not previously received a ROS1 inhibitor.

About NSCLC
NSCLC is the most common form of lung cancer and is often characterised by specific genetic alterations, such as those in ALK, ROS1, or HER2. It can often metastasise (i.e., spread) to the central nervous system. It primarily affects working-age individuals. Current treatments may have efficacy and/or tolerability limitations that leave unmet need for patients.⁹

GSK in oncology
Our ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women's cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates Ris-Rez targeting B7-H3 and Mo-Rez targeting B7-H4, and velzatinib, a highly selective KIT tyrosine kinase inhibitor.

About GSK 
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

GSK enquiries
Media:	Tim Foley	+44 (0) 20 8047 5502	(London)
	Madison Goring	+44 (0) 20 8047 5502	(London)
	Kathleen Quinn	+1 202 603 5003	(Washington DC)
	Alison Hunt	+1 540 742 3391	(Washington DC)
Investor Relations:	Constantin Fest	+44 (0) 7831 826525	(London)
	James Dodwell	+44 (0) 20 8047 2406	(London)
	Mick Readey	+44 (0) 7990 339653	(London)
	Steph Mountifield	+44 (0) 7796 707505	(London)
	Sam Piper	+44 (0) 7824 525779	(London)
	Jeff McLaughlin	+1 215 751 7002	(Philadelphia)
	Frannie DeFranco	+1 215 751 3126	(Philadelphia)

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025, and GSK's Q1 Results for 2026.

Registered in England & Wales:
No. 3888792

Registered Office:
79 New Oxford Street
London
WC1A 1DG

¹ Jideytro US Prescribing Information.
² Nuvalent press release issued 19 November 2025: Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC. Available at: 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.
³ GSK press release issued 15 July 2026: GSK completes acquisition of Nuvalent, Inc. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-completes-acquisition-of-nuvalent-inc/.
⁴ Solomon B. Validating ROS1 Rearrangements As a Therapeutic Target in Non–Small-Cell Lung Cancer. J Clin Oncol 33, 972-974(2015).
⁵ Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024; 74(3): 229-263. doi:10.3322/caac.21834
⁶ GSK press release issued 10 July 2026: GSK's licensor Hansoh Pharma announces positive phase III results for Ris-Rez in China patient population. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-s-licensor-hansoh-pharma-announces-positive-phase-iii-results-for-ris-rez-in-china-patient-population/.
⁷ US Prescribing Information. To be available at: https://nuvalent.com/pdfs/jideytro-full-prescribing-information.pdf.
⁸ ClinicalTrials.gov. National Library of Medicine (US). Identifier NCT05118789, A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Available at: https://clinicaltrials.gov/study/NCT05118789.
⁹ Duma, N., Santana-Davila, R., & Molina, J. R. (2019). Non-Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clinic proceedings, 94(8), 1623–1640. https://doi.org/10.1016/j.mayocp.2019.01.013.

Dr. Drilon has served as a consultant to and/or received expense reimbursements from Nuvalent, Inc.

View original content to download multimedia:https://www.prnewswire.com/news-releases/jideytro-zidesamtinib-approved-in-the-us-for-previously-treated-ros1-positive-non-small-cell-lung-cancer-302832452.html

SOURCE GSK plc

FAQ

What did the FDA approve for GSK (NYSE:GSK) on July 22, 2026 in ROS1-positive NSCLC?

The FDA approved Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer previously treated with a ROS1 kinase inhibitor. According to GSK, this is its first approved lung cancer medicine and part of its expanding targeted oncology portfolio.

What were the key ARROS-1 trial results supporting Jideytro approval for GSK (GSK) investors?

ARROS-1 showed a 44% objective response rate in 117 ROS1-positive NSCLC patients previously treated with a ROS1 inhibitor. According to GSK, duration-of-response rates were 82% at six months and 69% at 12 months, including responses in patients with brain metastases and resistance mutations.

What is the approved indication for Jideytro (zidesamtinib) in the US for GSK’s portfolio?

Jideytro is approved to treat adult patients with locally advanced or metastatic ROS1-positive NSCLC who have received a prior ROS1 kinase inhibitor. According to GSK, the drug was designed for high ROS1 selectivity, resistance mutation coverage and brain penetration to address key treatment challenges.

What side effects were reported with Jideytro in GSK’s ARROS-1 safety population?

Common adverse reactions (≥15%) included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea in 446 treated patients. According to GSK, Jideytro’s next-generation design aimed to pair durable responses with a tolerable profile, though ongoing monitoring of safety remains important for clinical use.

How does Jideytro approval fit into GSK’s broader oncology and Nuvalent acquisition strategy?

The approval makes Jideytro GSK’s first lung cancer medicine and a key asset from its Nuvalent acquisition. According to GSK, additional Nuvalent-derived candidates, including neladalkib (NVL-655) and NVL-330, are in development for ALK- and HER2-altered NSCLC, complementing other late-stage oncology programs.

Is GSK studying Jideytro (zidesamtinib) beyond previously treated ROS1-positive NSCLC patients?

Yes. According to GSK, zidesamtinib continues to be evaluated in the global ARROS-1 phase I/II trial, including first-line treatment for patients who have not previously received a ROS1 inhibitor. The study also includes other ROS1-positive solid tumours, potentially broadening future clinical applications.

What does the early FDA decision on Jideytro mean for GSK shareholders and timelines?

The FDA approved Jideytro ahead of the original 18 September 2026 target action date, potentially accelerating market entry. According to GSK, the rapid progression from development to approval reflects urgent unmet need in ROS1-positive NSCLC and strengthens its position in targeted lung cancer therapies.