Lurbinectedin

On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024. Full prescribing information for Imdelltra will be posted on Drugs@FDA . Efficacy was evaluated in DeLLphi-304 (NCT05740566), a multicenter, randomized, open-label trial in patients with SCLC with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody. In DeLLphi-304, 509 patients were randomized (1:1) to receive either tarlatamab-dlle or investigator's choice of standard of care (SOC) chemotherapy (topotecan, lurbinectedin, or amrubicin) until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall survival (OS). Key secondary efficacy outcome measures included progression-free survival (PFS) based on investigator assessment per RECIST v 1.1 and select patient-reported outcomes. Median OS was 13.6 months (95% CI: 11.1, not evaluable) in the tarlatamab-dlle arm and 8.3 months (95% CI: 7.0, 10.2) in the SOC arm (hazard ratio [HR] 0.60 [95% CI: 0.47, 0.77]; p-value <0.001). Median PFS was 4.2 months (95% CI: 3.0, 4.4) and 3.2 months (95% CI: 2.9, 4.2) in the respective arms (HR 0.72 [95% CI: 0.59, 0.88]; p-value <0.001). The trial also demonstrated a statistically significant improvement in dyspnea at week 18 for patients randomized to tarlatamab-dlle compared to SOC. The prescribing information for tarlatamab-dlle includes a Boxed Warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), as well as warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. The recommended tarlatamab-dlle dose is 1 mg on Cycle 1, Day 1 followed by 10 mg on Days 8, 15, and every two weeks thereafter until disease progression or unacceptable toxicity. This review was conducted under Project Orbis , an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada (HC), and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies. This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid , a voluntary submission from the applicant to facilitate the FDA's assessment. The FDA approved this application 1 month ahead of the FDA goal date. This application was granted priority review. Tarlatamab-dlle received breakthrough designation. 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 . Content current as of: 11/19/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif. , Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA ® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA's prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. Additionally, the National Comprehensive Cancer Network ® (NCCN ® ) Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) were recently updated to include tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. 1 * The global Phase 3 DeLLphi-304 study met its primary endpoint, demonstrating that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs. 8.3 months; hazard ratio (HR), 0.60; 95% confidence interval (CI): 0.47, 0.77; P < 0.001). 2 "The FDA's decision reinforces IMDELLTRA as a recognized standard of care for people living with extensive stage small cell lung cancer whose disease progressed on or after frontline therapy," said Jay Bradner , M.D., executive vice president, Research and Development , at Amgen . "We are committed to delivering transformative medicines for patients facing challenging cancers, and we are currently focused on rapidly developing IMDELLTRA in earlier stages of disease and earlier lines of therapy for small cell lung cancer patients." "For far too long, people living with small cell lung cancer had few options once their first treatment stopped working," said Laurie Fenton Ambrose , co-founder, president, and CEO, GO2 for Lung Cancer . "Today's full approval is an important step forward, reinforcing long-awaited progress for patients facing this devastating disease." The safety profile for IMDELLTRA in DeLLphi-304 was consistent with its known profile, with fewer Grade 3 or greater adverse events in the IMDELLTRA arm than in the chemotherapy arm (54% vs 80%). The most common Grade 3 or greater treatment-related adverse events (TRAEs) were neutropenia (4%) and lymphopenia (4%) with IMDELLTRA and anemia (28%) and neutropenia (22%) with SOC chemotherapy. Cytokine release syndrome (CRS) with IMDELLTRA primarily occurred after the first two doses and was primarily low grade (42% Grade 1; 13% Grade 2; 1% Grade 3). No Grade 4 or Grade 5 CRS events were reported. 2 "Due to its distinctive biology and aggressive nature, small cell lung cancer has long been particularly challenging to treat, with limited progress compared to many other cancers. After years of research efforts, DeLLphi-304 was the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in its setting, leading to NCCN Guidelines ® Category 1 status for tarlatamab and further demonstrating the validity of this treatment approach in small cell lung cancer," said Charles M. Rudin , M.D., Ph.D., deputy director, Memorial Sloan Kettering Cancer Center , and principal investigator.* "Importantly, data from DeLLphi-304 reflected in today's approval also equip physicians with a greater understanding of managing treatment with bispecific T-cell engager therapy." Amgen 's robust IMDELLTRA development program includes the DeLLphi clinical trials, which evaluate IMDELLTRA as a monotherapy and as part of combination regimens, including in both earlier stages of SCLC and earlier lines of treatment. About the Phase 3 DeLLphi-304 Study DeLLphi-304 is a global Phase 3, randomized, controlled, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA as a treatment for patients living with SCLC who progressed on or after a single line of platinum-based chemotherapy. 3 Five hundred and nine patients were randomized to receive either IMDELLTRA or local SOC chemotherapy (topotecan in all countries except Japan ; lurbinectedin in the U.S. , Canada , Australia , Singapore , Korea ; and amrubicin in Japan ). 3,4 The primary outcome measure of the trial is OS. 3 Key secondary outcome measures include progression-free survival (PFS) and patient-reported outcomes (PROs) including disease-related symptoms, physical function, and quality of life. 3 Results from DeLLphi-304 were reviewed as a late-breaking presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine . 2,5 About Tarlatamab Clinical Trials Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with SOC therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with SOC chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without anti-programmed death ligand 1 (PD-L1) in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; and DeLLphi-312, a Phase 3 study evaluating tarlatamab as an induction and maintenance therapy in first-line treatment of ES-SCLC in combination with carboplatin, etoposide and durvalumab. 6 For more information, please visit www.tarlatamabclinicaltrials.com . About Small Cell Lung Cancer (SCLC) SCLC is one of the most aggressive and devastating forms of solid tumor cancers. In the United States , the five-year relative survival rate for SCLC is 5-10% across all stages combined. 7 Each year, SCLC accounts for approximately 13-15% of the more than 2.4 million cases of lung cancer diagnosed worldwide, including around 227,000 cases in the United States . 8-10 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options. 9 About IMDELLTRA ® (tarlatamab-dlle) IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell. 11,12 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target. 13,14 INDICATION IMDELLTRA ® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME WARNINGS AND PRECAUTIONS ADVERSE REACTIONS DOSAGE AND ADMINISTRATION: Important Dosing Information Please see IMDELLTRA ® full Prescribing Information , including BOXED WARNINGS. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube , and Threads . 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CONTACT: Amgen , Thousand Oaks Annik Allen , 917-288-9136 (media) Elissa Snook , 609-251-1407 (media) Casey Capparelli , 805-447-1746 (investors) *NCCN Disclaimer: NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. REFERENCES View original content to download multimedia: https://www.prnewswire.com/news-releases/fda-grants-full-approval-to-amgens-imdelltra-in-extensive-stage-small-cell-lung-cancer-302620865.html SOURCE Amgen