Form 6-K GSK plc For: Jul 22
Tweet
Share
E-mail
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of July 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 22 July 2026, London UK
Jideytro (zidesamtinib)
approved in the US for previously treated ROS1-positive non-small
cell lung cancer
●
Approval
based on ARROS-1 phase I/II trial demonstrating meaningful and
durable responses in patients with locally advanced or metastatic
disease[1]
●
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
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 data[6] 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 here[7].
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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: July
22, 2026
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
- Share Buyback Transaction Details July 16 – July 22, 2026
- EnviroTech Solutions Provides Asbestos Abatement Services in Winter Park, FL
Create E-mail Alert Related Categories
SEC FilingsSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
