AstraZeneca UK Ltd.

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).Full prescribing information for Imfinzi will be posted on Drugs@FDA. Efficacy and SafetyEfficacy was evaluated in NIAGARA (NCT03732677), a randomized, open-label, multicenter, Phase III trial enrolling 1,063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Patients were randomized (1:1) to receive neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery alone.The major efficacy outcome was event-free survival (EFS) by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. At a pre-specified interim analysis, the trial demonstrated a statistically significant improvement in EFS and OS. Median EFS was not reached (NR) (95% CI: NR, NR) in the durvalumab with chemotherapy arm and 46.1 months (95% CI: 32.2, NR) in the chemotherapy arm (hazard ratio 0.68 [95% CI: 0.56, 0.82]; two-sided p-value <0.0001). Median OS was not reached in either arm (hazard ratio 0.75 [95% CI: 0.59, 0.93]; two-sided p-value=0.0106).Adverse reactions were consistent with prior experience with durvalumab with platinum-based chemotherapy.The recommended durvalumab dose for patients with a body weight of ≥30 kg is 1,500 mg every 3 weeks with chemotherapy (neoadjuvant treatment) and 1,500 mg as a single agent every 4 weeks (adjuvant treatment). The recommended durvalumab dose for patients with a body weight <30 kg is 20 mg/kg with chemotherapy every 3 weeks (neoadjuvant treatment) and 20 mg/kg as a single agent every 4 weeks (adjuvant treatment). Treatment should continue until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.

Both Tagrisso and Imfinzi have been recommended by England’s NICE to treat patients with lung cancer in England and Wales. Credit: Roland Magnusson via Getty Images. AstraZeneca has received two separate recommendations from England’s National Institute for Health and Care Excellence (NICE) for the use of its lung cancer treatments, Tagrisso (osimertinib) and Imfinzi (durvalumab), within England and Wales’s National Health Service (NHS). Tagrisso has been recommended as an adjuvant therapy following complete surgical resection in adults with stage 1B to 3A non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor (EGFR) exon 19 deletions or exon 21 substitution mutations. The NICE decision was supported by data from the Phase III ADAURA trial (NCT05120349), which demonstrated that post-surgical treatment with Tagrisso reduced the relative risk of disease recurrence or death by 83% compared to placebo in patients with stage 2 to 3A EGFR-mutated NSCLC. At two years, 90% of patients receiving Tagrisso were disease-free, compared to 44% in the placebo group. Among patients with stage 1B to 3A disease, 89% administered with AstraZeneca’s treatment were alive and disease-free at 24 months compared to 52% in the placebo group. Meanwhile, Imfinzi has been recommended in combination with the chemotherapy etoposide and either carboplatin or cisplatin for the treatment of adults with untreated extensive-stage small cell lung cancer (SCLC). NICE’s decision was based on results from the Phase III CASPIAN trial (NCT03043872), which demonstrated that adding Imfinzi to standard chemotherapy provided a significant and sustained overall survival (OS) benefit. At three years, the Imfinzi combination reduced the risk of death by 29% compared to chemotherapy alone. Lung cancer remains the most common cause of cancer-related deaths in the UK, and accounts for nearly 50,000 new cases annually, according to Cancer Research UK. A 2023 report from Frontier Economics estimated that lung cancer costs the UK economy £699m each year. While AstraZeneca has established itself as a key player in lung cancer treatment, Tagrisso faces competition. Johnson & Johnson (J&J) announced updated results from its Phase III MARIPOSA trial (NCT04487080) earlier this month, which tested the combination of its lung cancer drugs Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). J&J claims the combination demonstrated a statistically significant OS improvement over Tagrisso by more than one year, though detailed data has not yet been disclosed. Despite the pressure from J&J, AstraZeneca anticipates strong commercial performance from its therapies. Tagrisso and Imfinzi are projected to generate global sales of $8bn and $7bn, respectively, by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. AstraZeneca UK president Tom Keith-Roach said: “This is fantastic news for lung cancer patients. We are proud that these decisions by NICE mean we’ve had 28 positive recommendations by NICE and the Scottish Medicines Consortium since 2021 across multiple cancer types and stages.”

A UK study has shown that a drug currently used to treat severe asthma could be re-purposed for use in emergency settings, potentially representing the first new treatment for asthma attacks in 50 years. The phase 2 ABRA study, led by scientists from King’s College London and sponsored by the University of Oxford, found that a single dose of AstraZeneca’s benralizumab could be more effective when injected at the point of exacerbation compared to currently used steroid tablets. The trial randomised patients at high risk of an asthma or chronic obstructive pulmonary disease (COPD) attack to receive benralizumab injection, standard-of-care prednisolone, or benralizumab plus prednisolone. Results published in The Lancet Respiratory Medicine showed that respiratory symptoms of cough, wheeze, breathlessness and sputum were found to be better with benralizumab after 28 days, and that four times fewer patients in the benralizumab group failed treatment compared to prednisolone after 90 days. The research, conducted with support from AstraZeneca UK, also showed that treatment with benralizumab took longer to fail, meaning fewer visits to a doctor or hospital for patients, and the drug was associated with an improvement in quality of life. Benralizumab is already authorised under the brand name Fasenra as a maintenance treatment for severe eosinophilic asthma and is designed to target specific white blood cells called eosinophils. More than one billion people globally are affected by asthma and COPD, a chronic respiratory disease, with eosinophilic exacerbations accounting for up to 30% of COPD flare-ups and almost 50% of asthma attacks. Steroids such as prednisolone can reduce inflammation in the lungs but have severe side effects, such as diabetes and osteoporosis, and many patients fail treatment. Lead investigator of the trial, Mona Bafadhel, King’s Centre for Lung Health said the findings could be a “game changer for people with asthma and COPD”. She said: “Benralizumab is a safe and effective drug already used to manage severe asthma. We’ve used the drug in a different way – at the point of an exacerbation – to show that it’s more effective than steroid tablets, which is the only treatment currently available.” The researchers are now hoping to launch a two-year phase 3 trial of the drug in 2025.