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Indicateby check mark whether the registrant by furnishing the informationcontained in this Form is also thereby furnishing the informationto the Commission pursuant to Rule 12g3-2(b) under the SecuritiesExchange Act of 1934.

Datroway (datopotamabderuxtecan or Dato-DXd) has been approved in the US for thetreatment of adult patients with locally advanced ormetastatic EGFR-mutated non-small cell lung cancer (NSCLC) whohave received prior EGFR-directed therapy and platinum-basedchemotherapy.

This indication is approved under accelerated approval based onobjective response rate (ORR) and duration of response (DoR).Continued approval for this indication may be contingent uponverification and description of clinical benefit in a confirmatorytrial.

The approval follows PriorityReview and Breakthrough TherapyDesignation by the Foodand Drug Administration (FDA) based on results from a subgroupanalysis of the TROPION-Lung05 PhaseII trial and supported by data from the TROPION-Lung01 PhaseIII trial.

Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute andinvestigator in both trials, said: "Addressing disease progressionin patients with advanced EGFR-mutated lung cancer after prior targeted therapyand chemotherapy is very challenging with limited later-linetreatment options available. The US approval of datopotamabderuxtecan introduces a novel and needed treatment option topatients with advanced disease."

Dave Fredrickson, Executive Vice President, Oncology HaematologyBusiness Unit, AstraZeneca, said: "This first approvalof Datroway in lung cancer provides a much-needed optionto patients with advanced EGFR-mutated lung cancer whose disease has becomeresistant to past treatments, regardless of the driving mutation.We have long supported patients with EGFR-mutated lung cancer and are proud to bringanother innovative treatment option to thiscommunity."

Ken Keller, Global Head of Oncology Business, and President andCEO, Daiichi Sankyo, Inc, said: "With today's acceleratedapproval, Datroway is now the first TROP2-directed medicineavailable for certain patients in the US living with lung cancer.We remain committed to our extensive clinical development programmeto further identify where Datroway may be used in other types of lung andbreast cancer."

Andrea E. Ferris, President and CEO, LUNGevity, said: "For peoplewith advanced EGFR-mutated non-small cell lung cancer whose diseaseprogresses on initial treatments, additional options are limited.Today's approval of Datroway offers a new treatment option for patientswhose disease has progressed following treatment withan EGFR-directed therapy andchemotherapy."

In TROPION-Lung05 and TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% (95%confidence interval [CI]: 35-54) in patients with previouslytreated locally advanced or metastatic EGFR-mutated NSCLC (n=114) as assessed by blindedindependent central review (BICR). Complete responses were seen in4.4% of patients and partial responses were seen in 40% ofpatients. The median DoR was 6.5 months (95% CI:4.2-8.4).

The safety profile of Datroway was evaluated in a pooled analysis of 125patients in the TROPION-Lung05, TROPION-Lung01 andTROPION-PanTumor01 trials. The safety profile observed across thesetrials was consistent with the known profile of this medicine withno new safety concerns identified.

Datroway is a specificallyengineered TROP2-directed DXd antibody drug conjugate (ADC)discovered by Daiichi Sankyo and being jointly developed andcommercialised by AstraZeneca and DaiichiSankyo.

AstraZeneca and Daiichi Sankyo areevaluating Datroway alone and with Tagrisso (osimertinib) in other advanced ormetastatic EGFR-mutated NSCLC settings inthe TROPION-Lung14 and TROPION-Lung15 PhaseIII trials.

Following approval in the US, an amount of $45 million is due fromAstraZeneca to Daiichi Sankyo as a milestone payment forthe locally advanced or metastatic EGFR-mutated NSCLC indication. Salesof Datroway in the US are recognized by Daiichi Sankyo.For further details on the financial arrangements, please consultthe collaboration agreement from July2020.

Nearly 2.5 million lung cancer cases were diagnosed globally in2022.1 Lungcancer is broadly split into small or non-small cell lung cancer,the latter accounting for about 87% of cases.2 Approximately10 to 15% of patients with NSCLC in the US and Europe, and 30 to40% of patients in Asia have an EGFR mutation.3,4 Themajority of EGFR mutations occur in tumours of nonsquamoushistology.5 TROP2is a protein broadly expressed in the majority of NSCLCtumours.6

For patients with tumours that have an EGFR mutation, the established 1st-line treatmentin the metastatic setting includes EGFR-directed therapy with or without platinum-basedchemotherapy.7 Whilethese therapies have improved outcomes in earlier lines oftreatment, most patients eventually experience disease progressionand receive subsequent therapies.8-11

TROPION-Lung05 is aglobal, multicentre, single-arm, open-label Phase II trialevaluating the efficacy and safety of Datroway in patients with locally advanced ormetastatic NSCLC with actionable genomic alterations who haveprogressed on at least one EGFR-directed therapy and platinum-based chemotherapy.Patients receiving up to four prior lines of treatment with tumourswith one or more genomic alterationsincluding EGFR, ALK, ROS1, NTRK, BRAF, RET or MET were eligible for thetrial.

The primary endpoint of TROPION-Lung05 is ORR as assessed by BICR.Secondary efficacy endpoints include DoR, disease control rate(DCR), clinical benefit rate, PFS, time to response (TTR), OS andsafety. TROPION-Lung05 enrolled 137 patients globally in Asia,Europe and North America. For more information,visit ClinicalTrials.gov.

TROPION-Lung01 is aglobal, randomised, multicentre, open-label Phase III trialevaluating the efficacy and safety of Datroway versus docetaxel in adult patients withlocally advanced or metastatic NSCLC with and without actionablegenomic alterations who require systemic therapy following priortreatment. Patients with actionable genomic alterations werepreviously treated with an approved targeted therapy andplatinum-based chemotherapy. Patients without known actionablegenomic alterations were previously treated, concurrently orsequentially, with platinum-based chemotherapy and a PD-1 or PD-L1inhibitor.

The dual primary endpoints of TROPION-Lung01 are PFS as assessed byBICR and OS. Key secondary endpoints include investigator-assessedPFS, ORR, DoR, TTR, and DCR as assessed by both BICR andinvestigator, and safety. TROPION-Lung01 enrolled 590 patients inAsia, Europe, North America, Oceania and South America. For moreinformation visit ClinicalTrials.gov.

Primary results from TROPION-Lung01, as presented atthe ESMO 2023 Congress, showed Datroway demonstrated a statistically significantimprovement in PFS over docetaxel. OS resultswere presented atthe IASLC 2024 World Conference on Lung Cancer hosted by theInternational Association for the Study of Lung Cancer andsimultaneously published inthe Journal of ClinicalOncology in September2024.

TROPION-PanTumor01 is afirst-in-human, open-label, two-part, multicentre Phase I trialevaluating the safety and preliminary efficacyof Datroway in patients with advanced solid tumours thathave relapsed or are refractory to standard treatment or for whichno standard treatment is available. The dose escalation portion ofthe trial enrolled patients with NSCLC to assess the safety andtolerability of Datroway to determine the recommended dose forexpansion (6mg/kg). The dose expansion part of TROPION-PanTumor01enrolled several different cohorts including patients with NSCLC,triple-negative breast cancer (TNBC), HR-positive, HER2-negativebreast cancer, small cell lung cancer, urothelial, gastric,pancreatic, castration resistant prostate and oesophagealcancer.

Safety endpoints include dose-limiting toxicities and seriousadverse events. Efficacy endpoints include ORR, DoR, TTR, PFS andOS. Pharmacokinetic, biomarker and immunogenicity endpoints alsoare being evaluated. TROPION-PanTumor01 enrolled 890 patients inAsia and North America. For more information,visit ClinicalTrials.gov.

Datroway (datopotamabderuxtecan; datopotamab deruxtecan-dlnk in the US only) is aTROP2-directed ADC. Designed using Daiichi Sankyo's proprietary DXdADC Technology, Datroway is one of six DXd ADCs in the oncologypipeline of Daiichi Sankyo, and one of the most advanced programmesin AstraZeneca's ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1monoclonal antibody, developed in collaboration with SapporoMedical University, attached to a number of topoisomerase Iinhibitor payloads (an exatecan derivative, DXd) viatetrapeptide-based cleavable linkers.

Datroway is approved inmore than 30 countries worldwide for the treatment of adultpatients with unresectable or metastatic HR-positive, HER2-negative(IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have receivedprior endocrine-based therapy and chemotherapy for unresectable ormetastatic disease based on the results fromthe TROPION-Breast01 trial.

Datroway is available inthe US under accelerated approval for the treatment of adultpatients with locally advanced ormetastatic EGFR-mutated NSCLC who have receivedprior EGFR-directed therapy and platinum-based chemotherapybased on results from the TROPION-Lung05 and TROPION-Lung01 trials.Continued approval for this indication in the US may be contingentupon verification and description of clinical benefit in aconfirmatory trial. Datroway is approved in Russia for the samepopulation.

A comprehensive global clinical development programme isunderway with more than 20 trials evaluating the efficacy andsafety of Datroway across multiple cancers, including NSCLC,TNBC and HR-positive, HER2-negative breast cancer. Theprogramme includes eight Phase III trials in lung cancer and fivePhase III trials in breast cancerevaluating Datroway as a monotherapy and in combination withother anticancer treatments in varioussettings.

AstraZeneca and Daiichi Sankyo entered into a global collaborationto jointly develop and commercialise Enhertu in March2019 and Datroway in July2020, except in Japan whereDaiichi Sankyo maintains exclusive rights for each ADC. DaiichiSankyo is responsible for the manufacturing and supplyof Enhertu and Datroway.

AstraZeneca is working to bring patients with lung cancer closer tocure through the detection and treatment of early-stage disease,while also pushing the boundaries of science to improve outcomes inthe resistant and advanced settings. By defining new therapeutictargets and investigating innovative approaches, the Company aimsto match medicines to the patients who can benefitmost.

The Company's comprehensive portfolio includes leading lung cancermedicines and the next wave of innovations,including Tagrisso and Iressa (gefitinib); Imfinzi and Imjudo; Enhertu (trastuzumab deruxtecan)and Datroway in collaboration DaiichiSankyo; Orpathys (savolitinib) in collaboration withHUTCHMED; as well as a pipeline of potential new medicines andcombinations across diverse mechanisms ofaction.

AstraZeneca is a founding member of the Lung Ambition Alliance, aglobal coalition working to accelerate innovation and delivermeaningful improvements for people with lung cancer, including andbeyond treatment.

AstraZeneca is leading a revolution in oncology with the ambitionto provide cures for cancer in every form, following the science tounderstand cancer and all its complexities to discover, develop anddeliver life-changing medicines to patients.

The Company's focus is on some of the most challenging cancers. Itis through persistent innovation that AstraZeneca has built one ofthe most diverse portfolios and pipelines in the industry, with thepotential to catalyse changes in the practice of medicine andtransform the patient experience.

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-ledbiopharmaceutical company that focuses on the discovery,development, and commercialisation of prescription medicines inOncology, Rare Diseases, and BioPharmaceuticals, includingCardiovascular, Renal & Metabolism, and Respiratory &Immunology. Based in Cambridge, UK, AstraZeneca's innovativemedicines are sold in more than 125 countries and used by millionsof patients worldwide. Please visit astrazeneca.com andfollow the Company on social media @AstraZeneca.

1. World Health Organization. GlobalCancer Observatory: Lung. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.Accessed May 2025.

2. American Cancer Society. KeyStatistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html.Accessed May 2025.

3. Szumera-Ciećkiewicz A, etal. EGFR mutation testing oncytological and histological samples in non-small cell lung cancer:a Polish, single institution study and systematic review ofEuropean incidence. Int J ClinExp Pathol.2013;6(12): 2800-2812.

4. Ellison G, etal. EGFR mutationtesting in lung cancer: a review of available methods and their usefor analysis of tumour tissue and cytologysamples. J ClinPathol.2013;66(2): 79-89.

6. Mito R, et al. Clinical impact ofTROP2 in non-small lung cancers and its correlation with abnormalP53 nuclear accumulation. PatholInt.2020;70(5): 287-294.

7. American Cancer Society. TargetedDrug Therapy for Non-Small Cell Lung Cancer. Availableat: https://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/targeted-therapies.html. Accessed May 2025.

11. Han B, et al. Efficacy ofpemetrexed-based regimens in advanced non-small cell lung cancerpatients with activating epidermal growth factor receptor mutationsafter tyrosine kinase inhibitor failure: a systematicreview. Onco TargetsTher. 2018;11:2121-9.

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	By: /s/Adrian Kemp
	Name:Adrian Kemp
	Title:Company Secretary