Lurbinectedin
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed small cell lung carcinoma 7 milestones | |||||
| Filed | Japan (PMDA) | Zepzelca | small cell lung carcinoma | 2026-06-23 | “Merck (MRK.DE) has submitted a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Zepzelca® (lurbinectedin)” pharmamar.com ↗ |
| Filed | EU (EMA) | Zepzelca | small cell lung carcinoma | 2025-10-03 | “PharmaMar has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), which is currently under review.” pharmamar.com ↗ |
| Filed | EU (EMA) | Zepzelca | small cell lung carcinoma | 2025-05-21 | “has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Zepzelca® (lurbinectedin)” pharmamar.com ↗ |
| Filed | China (NMPA) | — | small cell lung carcinoma | 2023-06-07 | “New Drug Application (NDA) submission of lurbinectedin has been accepted by the Centre for Drug Evaluation (CDE)” pharmamar.com ↗ |
| Filed | UK (MHRA) | Zepzelca | small cell lung carcinoma | 2022-05-04 | “submitted a conditional marketing authorization application to the UK’s MHRA for the treatment with lurbinectedin in adult patients with metastatic Small Cell Lung Cancer” pharmamar.com ↗ “has submitted a conditional marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).” pharmamar.com ↗ |
| Filed | Other | Zepzelca | small cell lung carcinoma | 2022-03-08 | “In December 2020, the company initiated a New Drug Submission for Zepzelca in SCLC with Health Canada's Therapeutic Products Directorate” jazzpharma.com ↗ “绿 叶 制 药 已 在 中 国 香 港 提 交Lurbinectedin的 新 药 上 市 申 请.” luye.com ↗ “Lurbinectedin已 在 中 国 香 港 地 区 提 交 新 药 上 市 申 请” luye.com ↗ |
| Filed | US (FDA) | Zepzelca | small cell lung carcinoma | — | “In December 2019 , PharmaMar submitted an NDA to FDA for accelerated approval of lurbinectedin for relapsed SCLC” jazzpharma.com ↗ “we have submitted a supplemental New Drug Application for Zepzelca” jazzpharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Zepzelca | — | 2026-05-29 | europa.eu ↗ |
| Label expansion | US (FDA) | ZEPZELCA | — | 2025-10-02 | fda.gov ↗ |
| Approved | US (FDA) | ZEPZELCA | — | 2020-06-15 | fda.gov ↗ |
Trials 56
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT05636111 | Jul 2023 → Dec 2026 expected | ovarian cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05244239 | Jul 2022 → Jul 2026 overdue | small cell lung carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT05101265 | Mar 2021 → Jun 2025 | neoplasm | PharmaMar | Unknown | No outcome recorded |
| Phase 1 | NCT04638491 | Nov 2020 → Nov 2023 | neoplasm | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04610658 | Nov 2020 → Mar 2023 | small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 1 | NCT01980667 | Jul 2014 → Jan 2017 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01831089 | Sep 2013 → Jul 2016 | breast cancer, head and neck carcinoma, non-small cell lung carcinoma, ovarian cancer +1 | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT02210364 | Apr 2013 → Oct 2016 | breast cancer, colorectal cancer, malignant pancreatic neoplasm | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01405391 | Nov 2011 → Jan 2016 | — | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01970540 | May 2011 → Aug 2017 | endometrium adenocarcinoma, small cell lung carcinoma | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01314599 | May 2011 → Jul 2015 | acute leukemia | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01970553 | May 2011 → Oct 2013 | — | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT00877474 | Mar 2009 → Jun 2011 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1/214 trials | ||||||
| Phase 1/2 | NCT07153055 | Aug 2026 → Apr 2029 expected | small cell lung carcinoma | Misty Shields | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07141771 | Dec 2025 → Jun 2030 expected | small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06217536 | Oct 2024 → May 2026 | soft tissue sarcoma | University of California, San Francisco | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06385548 | May 2024 | endometrial cancer | Vall d'Hebron Institute of Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05918640 | Jul 2023 → Jul 2028 expected | Ewing sarcoma, childhood malignant neoplasm, desmoplastic small round cell tumor | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05876715 | Jun 2023 → Jun 2026 overdue | soft tissue sarcoma | ERLINDA M GORDON | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05734066 | May 2023 → Jan 2028 expected | Ewing sarcoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05099666 | Feb 2022 → Jul 2026 overdue | leiomyosarcoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05042934 | Sep 2021 → Aug 2022 | Ewing sarcoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04802174 | Jun 2021 → Dec 2025 overdue | small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04358237 | Sep 2020 → Sep 2023 | small cell lung carcinoma | Antonio Calles Blanco | Completed | No outcome recorded |
| Phase 1/2 | NCT04253145 | Dec 2019 → May 2025 | small cell lung carcinoma | Fundacion Oncosur | Unknown | No outcome recorded |
| Phase 1/2 | NCT02611024 | May 2016 → Jul 2025 | colorectal carcinoma, digestive system neuroendocrine neoplasm, endometrial carcinoma, gastric carcinoma +6 | PharmaMar | Completed | No outcome recorded |
| Phase 1/2 | NCT02684318 | Jul 2015 → Jul 2019 | breast cancer, cancer of unknown primary site, endometrial cancer, ovarian cancer | Poveda, Andrés, M.D. | Unknown | No outcome recorded |
| Phase 221 trials · 2 met primary | ||||||
| Phase 2 | NCT07459634 | Nov 2026 → Jan 2028 expected | small cell lung carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07640932 | Nov 2026 → Apr 2027 expected | small cell lung carcinoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07258147 | Oct 2026 → Dec 2027 expected | small cell lung carcinoma | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06501976 | Dec 2025 → Dec 2026 expected | small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07328425 | Nov 2025 → Oct 2030 expected | desmoplastic small round cell tumor | Italian Sarcoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07121478 | Sep 2025 → Mar 2027 expected | pancreatic neuroendocrine tumor | National Cancer Center, Korea | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06497530 | Dec 2024 → Dec 2026 expected | small cell lung carcinoma | Guangzhou Institute of Respiratory Disease | Recruiting | No outcome recorded |
| Phase 2 | NCT06228066 | Jun 2024 → Sep 2027 expected | bladder small cell carcinoma, neuroendocrine neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05572476 | Oct 2023 → May 2024 | small cell lung carcinoma | Institut Bergonié | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05574504 | May 2023 → Nov 2026 | metastatic malignant neoplasm, urothelial carcinoma | AdventHealth | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05800587 | Feb 2023 → Aug 2028 expected | non-small cell lung carcinoma, small cell lung carcinoma | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05578326 | Oct 2022 → Dec 2026 expected | small cell lung carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05229588 | Jun 2022 → Aug 2025 | digestive system cancer | HonorHealth Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT05126433 | Mar 2022 → Dec 2023 | metastatic neoplasm, neuroendocrine carcinoma, urothelial carcinoma | Jazz Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04607954 | Dec 2020 → Sep 2026 overdue | small cell lung carcinoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03213301 | Sep 2017 → Jun 2021 | malignant pleural mesothelioma | Swiss Cancer Institute | Completed | Met primary |
| Phase 2 | NCT02454972 | Aug 2015 → Sep 2020 | cancer | PharmaMar | Completed | Met primary |
| Phase 2 | NCT02451007 | Aug 2015 → Aug 2016 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 2 | NCT02448537 | Aug 2015 → Feb 2017 | sarcoma | Massachusetts General Hospital | Completed | Mixed |
| Phase 2 | NCT01951157 | Sep 2013 → Nov 2016 | non-small cell lung carcinoma | PharmaMar | Completed | No outcome recorded |
| Phase 2 | NCT01525589 | Jun 2012 → Oct 2018 | breast cancer | PharmaMar | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT06801834 | Apr 2025 → Oct 2029 expected | small cell lung carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT06496048 | Sep 2024 → Dec 2027 expected | small cell lung carcinoma | Luye Pharma Group Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06088290 | Sep 2023 → Aug 2029 expected | leiomyosarcoma | PharmaMar | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05153239 | Jul 2022 → Apr 2026 | small cell lung carcinoma | PharmaMar | Completed | Missed primary |
| Phase 3 | NCT05091567 | Nov 2021 → Jul 2024 overdue | small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT02566993 | Aug 2016 → Feb 2020 | small cell lung carcinoma | PharmaMar | Completed | Missed primary |
| Phase 3 | NCT02421588 | May 2015 → Oct 2018 | ovarian cancer | PharmaMar | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT04291937 | — | small cell lung carcinoma | Jazz Pharmaceuticals | Approved for marketing | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT05072106 Comparator | Jan 2021 → Jan 2022 | neoplasm | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT05063318 Comparator | Oct 2020 → Apr 2022 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1/2 | NCT06681220 Comparator | Feb 2026 → Dec 2029 expected | small cell lung carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05652686 Background | Sep 2023 → Dec 2027 expected | digestive system neuroendocrine neoplasm, large cell neuroendocrine carcinoma, prostate neuroendocrine neoplasm, small cell lung carcinoma | Phanes Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT07155174 Background | Nov 2025 → Apr 2029 expected | small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT07796100 Comparator | Dec 2026 → Jun 2030 expected | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07625644 Comparator | Aug 2026 → Jan 2030 expected | small cell lung carcinoma | SystImmune Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07365241 Comparator | Jul 2026 → Sep 2030 expected | small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06203210 Comparator | May 2024 → Apr 2027 expected | small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT05740566 Comparator | May 2023 → Jan 2025 overdue | small cell lung carcinoma | Amgen | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 83
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved by the MHRA as first-line maintenance therapy for extensive-stage small cell lung cancer in the United Kingdom immedica.com ↗
Zepzelca was submitted and approved with the European Medicines Agency (EMA) acting as the Reference Regulator. |
| 2026-09-24 | PharmaMar | Regulatory The United Kingdom approves Zepzelca® (lurbinectedin) by PharmaMar in combination with atezolizumab for first-line maintenance treatment of small cell lung cancer pharmamar.com ↗ |
| 2026-09-04 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in Kuwait immedica.com ↗
Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) has been approved as a maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide in Kuwait. |
| 2026-08-03 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in Qatar immedica.com ↗ |
| 2026-08-03 | PharmaMar | Regulatory Canada, Qatar and South Korea Approve PharmaMar’s Zepzelca® in combination with Atezolizumab for First-Line Maintenance Treatment of Small Cell Lung Cancer pharmamar.com ↗
With these latest authorizations, the lurbinectedin–atezolizumab combination is now approved in 18 territories worldwide, including the European Union and the United States. |
| 2026-06-23 | PharmaMar | Regulatory PharmaMar’s partner, Merck, has submitted a New Drug Application in Japan for Zepzelca® (lurbinectedin) regarding first line maintenance therapy in small cell lung cancer pharmamar.com ↗
PharmaMar (MSE: PHM), has announced that Merck (MRK.DE) has submitted a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Zepzelca® (lurbinectedin) regarding the first line maintenance treatment of small cell lung cancer (SCLC). |
| 2026-06-12 | PharmaMar | Results PharmaMar Reports Update on Phase III LAGOON Trial in Second Line for Small Cell Lung Cancer pharmamar.com ↗
Safety for lurbinectedin monotherapy is better compared to the control group. |
| 2026-06-12 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Provides Update on Zepzelca® (lurbinectedin) Phase 3 LAGOON Trial in Second-Line Small Cell Lung Cancer jazzpharma.com ↗
The trial did not meet its primary endpoint of overall survival (OS) evaluating Zepzelca as monotherapy or in combination with irinotecan compared to investigators' choice of topotecan or irinotecan. |
| 2026-06-01 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved by the European Commission as first-line maintenance therapy for extensive-stage small cell lung cancer immedica.com ↗ |
| 2026-06-01 | PharmaMar | Regulatory The European Commission approves PharmaMar’s Zepzelca® (lurbinectedin) for the treatment of extensive-stage small cell lung cancer in combination with atezolizumab pharmamar.com ↗ |
| 2026-04-20 | PharmaMar | Regulatory PharmaMar’s Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) has obtained another three approvals as first-line maintenance therapy for small cell lung cancer pharmamar.com ↗ |
| 2026-04-08 | Lotus Pharmaceutical | Regulatory Lotus Pharmaceutical Announces TFDA Approval of Zepzelca® (lurbinectedin) in Combination with Immunotherapy as First-Line Maintenance Therapy for ES-SCLC lotuspharm.com ↗
Zepzelca® (lurbinectedin), its licensed oncology product, has received approval from the Taiwan Food and Drug Administration (TFDA) for use in combination with atezolizumab as a first-line maintenance treatment for adult patients with extensive-stage small-cell lung cancer (ES-SCLC). |
| 2026-03-27 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab receives positive CHMP opinion as first-line maintenance therapy for extensive-stage small cell lung cancer immedica.com ↗
The CHMP’s positive opinion represents an important step towards bringing this new treatment option to patients in Europe. |
| 2026-03-27 | PharmaMar | Regulatory PharmaMar receives recommendation for the approval from the European Medicines Agency for Zepzelca® (lurbinectedin) for the treatment of extensive-stage small cell lung cancer in combination with the immunotherapy atezolizumab pharmamar.com ↗
PharmaMar (MSE: PHM), has announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zepzelca® (lurbinectedin) |
| 2026-03-23 | PharmaMar | Regulatory PharmaMar’s treatment for small cell lung cancer approved as first-line maintenance therapy in Taiwan pharmamar.com ↗
PharmaMar (MSE:PHM) a Spanish biopharmaceutical company with 40 years of experience, announced today that its treatment Zepzelca® (lurbinectedin), in combination with atezolizumab (Tecentriq®), has been approved by the Taiwan Food and Drug Administration (TFDA) as a first-line maintenance treatment for adult patients with advanced small cell lung cancer (SCLC). |
| 2025-11-28 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in United Arab Emirates (UAE) immedica.com ↗
Immedica today announced that the Emirates Drug Establishment has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. |
| 2025-11-24 | PharmaMar | Regulatory Swiss medical authority approves PharmaMar’s Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) combination as first-line maintenance therapy for extensive-stage small cell lung cancer pharmamar.com ↗
This is the first approval in Europe for lurbinectedin in this indication |
| 2025-10-03 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer roche.com ↗ |
| 2025-10-03 | PharmaMar | Regulatory FDA approves PharmaMar’s Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination as First-line Maintenance Therapy for Extensive-stage Small Cell Lung Cancer pharmamar.com ↗
PharmaMar (MSE:PHM) has announced that the U.S Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide[i]. |
| 2025-10-02 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer gene.com ↗
FDA Approves Genentech’s Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer |
| 2025-10-02 | Jazz Pharmaceuticals | Regulatory FDA Approves Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer jazzpharma.com ↗
The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options. |
| 2025-06-10 | PharmaMar | Regulatory FDA Grants Priority Review for Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination in Extensive Stage Small Cell Lung Cancer pharmamar.com ↗
PharmaMar (MSE:PHM) has announced that the U.S Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab. |
| 2025-06-10 | Jazz Pharmaceuticals | Regulatory Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer jazzpharma.com ↗ |
| 2025-06-03 | Hoffmann-La Roche | Results Roche’s Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer roche.com ↗
The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. |
| 2025-06-03 | PharmaMar | Results PharmaMar presents at ASCO that the Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination significantly improves survival as first-line maintenance therapy for extensive-stage small cell lung cancer pharmamar.com ↗
The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone. |
| 2025-06-02 | Genentech, Inc. | Results Genentech’s Tecentriq Combined With Lurbinectedin Shows Significant Survival Benefit in Extensive-Stage Small Cell Lung Cancer gene.com ↗
The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. |
| 2025-06-02 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Announces Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Significantly Improves Survival as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive results from the Phase 3 IMforte study of Zepzelca ® (lurbinectedin) in combination with atezolizumab (Tecentriq ® ) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab. |
| 2025-05-21 | PharmaMar | Regulatory PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumabin first-line maintenance therapy for extensive-stage small cell lung cancer pharmamar.com ↗
PharmaMar (MSE:PHM) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) |
| 2025-05-19 | PharmaMar | Regulatory PharmaMar’s Zepzelca® (lurbinectedin) receives commercialization approval for the treatment of relapsed small cell lung cancer in Argentina pharmamar.com ↗ |
| 2025-05-06 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces First Quarter 2025 Financial Results and Updates 2025 Financial Guidance jazzpharma.com ↗
The Company submitted a supplemental New Drug Application (sNDA) for Zepzelca's use in combination with atezolizumab as maintenance therapy in 1L extensive-stage (ES) SCLC for patients who have not progressed after induction chemotherapy. |
| 2025-04-28 | PharmaMar | Results PharmaMar presents eleven scientific publications at the Annual Meeting of the American Association for Cancer Research (AACR) pharmamar.com ↗
Finally, the studies also show the antitumor activity of lurbinectedin in NUT carcinoma—a rare type of cancer that forms in the head, neck and lungs. |
| 2025-04-24 | PharmaMar | Results PharmaMar´s lurbinectedin transformative data in combination with atezolizumab for small cell lung cancer will be shared as oral presentation at ASCO 2025 pharmamar.com ↗
“Statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) data for lurbinectedin (Zepzelca®) in combination with atezolizumab (Tecentriq®) underscore potential of first line maintenance therapy for extensive stage small cell lung cancer (ES-SCLC), a much-needed advancement for patients” |
| 2025-04-23 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Showcases Transformative Data at ASCO 2025, Highlighting Advances in Small Cell Lung Cancer, HER2+ Gastroesophageal Cancer and Diffuse Glioma jazzpharma.com ↗
Statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) data for Zepzelca ® (lurbinectedin) and atezolizumab (Tecentriq ® ) combination underscore potential of first-line maintenance therapy for extensive-stage small cell lung cancer, a much-needed advancement for patients |
| 2024-12-03 | PharmaMar | Regulatory PharmaMar’s Zepzelca® (lurbinectedin) receives approval in China for the treatment of Small Cell Lung Cancer pharmamar.com ↗
After the approval in China, lurbinectedin is now approved in 17 territories around the world. |
| 2024-10-30 | Lotus Pharmaceutical | Results Lotus Pharmaceutical's novel drug Zepzelca® (lurbinectedin) has demonstrated significantly superior efficacy lotuspharm.com ↗
Zepzelca® (lurbinectedin) when combined with atezolizumab, has shown statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared to treatment with atezolizumab alone. |
| 2024-10-15 | PharmaMar | Results PharmaMar Announces Positive and Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination in First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer pharmamar.com ↗
The combination of lurbinectedin and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone. |
| 2024-10-15 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Announces Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination in First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer jazzpharma.com ↗
The combination of Zepzelca and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone. |
| 2024-06-04 | PharmaMar | Results Results presented at ASCO demonstrating the synergy of PharmaMar’s combination of lurbinectedin with irinotecan in patients with relapsed small cell lung cancer pharmamar.com ↗
Particularly encouraging are the data drawn from the subgroup of 74 patients with a chemotherapy-free interval greater than 30 days (CTFI>30 days) with a response rate of 52.7% and a median response duration of 7.6 months. |
| 2024-04-25 | PharmaMar | Results PharmaMar study of the combination of lurbinectedin and irinotecan on Small Cell Lung Cancer has been selected for a presentation at ASCO pharmamar.com ↗
The results showed a clear synergy on combining these two compounds that strengthens the use of lurbinectedin. |
| 2024-01-29 | PharmaMar | Results PharmaMar presents new results for lurbinectedin at ASCO Genitourinary Cancers symposium pharmamar.com ↗
Clinical Benefit Rate was found in 56.3%, with Partial Response in 5 of 16 patients, 31%. |
| 2023-12-12 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of relapsed Small Cell Lung Cancer in Hong Kong pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that its licensing partner, Luye Pharma Group Ltd, has received marketing approval for Zepzelca® (lurbinectedin) by the Pharmacy and Poisons Board of the Hong Kong Special Administrative Region (SAR), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy. |
| 2023-12-04 | Luye Pharma Group Ltd. | Regulatory 绿叶制药创新药芦比替定在中国香港获批上市,将通过大湾区“港澳药械通”政策惠及全国患者 luye.com ↗ |
| 2023-12-04 | PharmaMar | Regulatory PharmaMar gets the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small-Cell Lung Cancer in Macao, China pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that its licensing partner, Luye Pharma Group Ltd, has received marketing approval for Zepzelca® (lurbinectedin) by the Pharmaceutical Administration Bureau in Macao for the treatment of adult patients with metastatic Small-Cell Lung Cancer (SCLC), with disease progression on or after platinum-based chemotherapy. |
| 2023-11-30 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present New Data Highlighting Advancements in Solid Tumors and Rare Blood Cancers at Upcoming Oncology Meetings jazzpharma.com ↗
Real-world data at NACLC reinforce clinical impact of Zepzelca ® (lurbinectedin) in small cell lung cancer |
| 2023-11-07 | PharmaMar | Regulatory PharmaMar announces the full approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Peru pharmamar.com ↗ |
| 2023-10-18 | PharmaMar | Results PharmaMar presents new data on lurbinectedin for Small Cell Lung Cancer at ESMO 2023 pharmamar.com ↗
The treatment achieved a confirmed response rate of 46.4%, including deep and durable responses that exceeded one year in some patients. |
| 2023-09-08 | PharmaMar | Results PharmaMar to present new data on lurbinectedin at the IASLC 2023 World Lung Cancer Congress pharmamar.com ↗
These results suggest that lurbinectedin may effectively extend the platinum-free interval while maintaining the possibility of platinum re-challenge, leading to improved outcomes for patients with relapsed SCLC. |
| 2023-07-21 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) approved by the Ministry of Health in Oman for the treatment of metastatic Small Cell Lung Cancer immedica.com ↗
Immedica’s product Zepzelca ® (lurbinectedin) has received approval by the Ministry of Health in Oman for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
| 2023-07-19 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Oman pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that its licensing partner, Immedica Pharma AB (Immedica), has received the full approval for the commercialization of Zepzelca® (lurbinectedin) by the Ministry of Health of Oman for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
| 2023-07-11 | Lotus Pharmaceutical | Regulatory Lotus Announces Zepzelca® (lurbinectedin) Has Acquired TFDA Accelerated Approval for the Treatment of Metastatic Small Cell Lung Cancer lotuspharm.com ↗
The approval is granted on an accelerated approval basis; the accelerated approval designation from the TFDA is designed to facilitate the development of medicines that may fill critical unmet medical needs. |
| 2023-07-11 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Taiwan pharmamar.com ↗
Lurbinectedin is now approved in 12 countries around the world. |
| 2023-06-07 | PharmaMar | Regulatory PharmaMar and Luye Pharma announce the acceptance of New Drug Application for lurbinectedin in China pharmamar.com ↗
the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Centre for Drug Evaluation (CDE) |
| 2023-05-12 | PharmaMar | Regulatory European Commission grants orphan drug designation to PharmaMar’s lurbinectedin for the treatment of Soft Tissue Sarcoma pharmamar.com ↗
PharmaMar (PHM:MSE) has announced today that the European Commission has designated lurbinectedin as an Orphan Medicinal Product for the treatment of Soft Tissue Sarcoma (STS), following a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). |
| 2023-04-17 | PharmaMar | Results PharmaMar to present new data on its compounds at AACR 2023 Congress pharmamar.com ↗
Moreover, in both in vitro and in vivo studies, as well as in biopsies obtained from patients, a possible predictive biomarker of response to lurbinectedin is identified, SLFN11. |
| 2023-03-15 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Data at 2023 AACR Annual Meeting Showcasing New Zepzelca® (lurbinectedin) Data and Expanded Oncology Pre-Clinical and Clinical Pipeline jazzpharma.com ↗
Results demonstrate that efficacy may be correlated to SLFN11 protein expression, consistent with the RNA level association. |
| 2023-03-08 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Switzerland pharmamar.com ↗
First approval in Europe for lurbinectedin. |
| 2023-01-31 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Israel pharmamar.com ↗
This approval allows Megapharm to market lurbinectedin in Israel in the following months. |
| 2023-01-24 | PharmaMar | Regulatory PharmaMar announces the full approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Mexico pharmamar.com ↗ |
| 2022-12-27 | PharmaMar | Regulatory PharmaMar receives Orphan Drug Designation for lurbinectedin from the Swiss Agency for Therapeutic Products for Malignant Mesothelioma pharmamar.com ↗
PharmaMar (PHM:MSE) has announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted Orphan Drug designation to lurbinectedin for the treatment of Malignant Mesothelioma. |
| 2022-09-23 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in South Korea pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that its licensing partner, Boryung Corporation, has received the conditional marketing approval for Zepzelca® (lurbinectedin) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
| 2022-09-08 | PharmaMar | Results PharmaMar announces the data to be presented at ESMO 2022 pharmamar.com ↗
Furthermore, they conclude that lurbinectedin provides an additional treatment option for relapsed SCLC patients, including those with platinum-sensitive disease. |
| 2022-08-05 | Immedica Pharma AB | Regulatory Zepzelca® (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency) immedica.com ↗
PharmaMar has announced today that Zepzelca® (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency). |
| 2022-08-05 | PharmaMar | Regulatory Lurbinectedin receives the Innovative Medicine Designation by the UK’s MHRA pharmamar.com ↗
PharmaMar has announced today that Zepzelca® (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency). |
| 2022-08-01 | Immedica Pharma AB | Regulatory ZepzelcaTM (lurbinectedin) approved in Qatar for the treatment of metastatic Small Cell Lung Cancer (SCLC) immedica.com ↗
Immedica Pharma AB announces that the MOPH Pharmacy & Drug Control Department has approved Zepzelca TM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC). |
| 2022-07-19 | PharmaMar | Regulatory Chinese health authorities approve lurbinectedin for “urgent clinical use” pharmamar.com ↗
PharmaMar’s partner in China, Luye Pharma Group Ltd, obtains permission from the Hainan regional health authorities to open an Expanded Access Program for Zepzelca® |
| 2022-06-09 | Luye Pharma Group Ltd. | Results Lurbinectedin二线治疗中国小细胞肺癌患者I期临床结果亮相2022 ASCO 年会 luye.com ↗ |
| 2022-06-01 | PharmaMar | Results PharmaMar announces abstracts to be presented at ASCO 2022 pharmamar.com ↗
The results show that these patients tended to maintain or better the tumor response obtained with the combination when switched to lurbinectedin monotherapy, including an increase in the rate of complete responses. |
| 2022-05-04 | PharmaMar | Regulatory PharmaMar has filed for approval of lurbinectedin for the treatment of metastatic Small Cell Lung Cancer in the UK pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that it has submitted a conditional marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). |
| 2022-05-03 | PharmaMar | Results Results of the phase II trial with lurbinectedin for the treatment of patients with relapsed Ewing Sarcoma pharmamar.com ↗
The trial achieved its primary endpoint of Overall Response Rate (ORR) of 14.3%, with a median Duration of Response (DoR) of 4.2 months. |
| 2022-03-08 | Luye Pharma Group Ltd. | Regulatory 绿叶制药在中国香港提交Lurbinectedin新药上市申请 luye.com ↗
绿 叶 制 药 集 团 宣 布,其 由PharmaMar许 可 引 进 的 抗 肿 瘤 创 新 药——Lurbinectedin已 在 中 国 香 港 地 区 提 交 新 药 上 市 申 请,用 于 治 疗 接 受 铂 类 药 物 化 疗 期 间 或 期 后 出 现 疾 病 进 展 的 复 发 性 小 细 胞 肺 癌(SCLC)成 人 患 者. |
| 2021-11-10 | PharmaMar | Results PharmaMar announces abstract to be presented at SITC 2021 pharmamar.com ↗
On this occasion, at the American Society for Immunotherapy Congress, we presented the first data on the combination of both strategies in patients with small cell lung cancer, with very good activity data and a manageable toxicity profile. |
| 2021-09-30 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca™ (lurbinectedin) for the treatment of relapsed stage III or metastatic small cell lung cancer in Canada pharmamar.com ↗ |
| 2021-09-22 | PharmaMar | Regulatory PharmaMar announces Singapore Health Sciences Authority approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received provisional marketing approval for Zepzelca® (lurbinectedin) by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing chemotherapy. |
| 2021-09-14 | PharmaMar | Regulatory PharmaMar announces that Australia approves Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer pharmamar.com ↗
The TGA approval of lurbinectedin has been granted under a provisional regulatory pathway. |
| 2021-09-02 | PharmaMar | Results PharmaMar announces abstracts to be presented during the IASLC 2021 World Conference on Lung Cancer pharmamar.com ↗
despite not meeting the primary endpoint of overall survival, the ATLANTIS study has some very important teachings for the treatment of relapsed small cell lung cancer, hence its selection for the Presidential Symposium. |
| 2021-09-01 | Immedica Pharma AB | Regulatory ZepzelcaTM (lurbinectedin) approved in United Arab Emirates (UAE) for the treatment of metastatic Small Cell Lung Cancer (SCLC) immedica.com ↗
Immedica Pharma AB announces that the United Arab Emirates Ministry of Health and Prevention has approved Zepzelca TM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC). |
| 2021-09-01 | PharmaMar | Regulatory PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in the United Arab Emirates pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that its licensing partner, Immedica Pharma AB (Immedica) has received marketing approval for Zepzelca® (lurbinectedin) by the Ministry of Health and Prevention of the United Arab Emirates (UAE) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression after platinum-based chemotherapy. |
| 2021-02-01 | PharmaMar | Results PharmaMar presents new data on Zepzelca® (lurbinectedin) in combination with irinotecan at an oral session at (rescheduled) IASLC 2020 pharmamar.com ↗
The Objective Response Rate (ORR) is 62% and a median Progression Free Survival (PFS) 6.2 months in second and third line patients with Small Cell Lung Cancer (SCLC). |
| 2021-01-13 | PharmaMar | Results PharmaMar will present new data for Zepzelca® (lurbinectedin) at rescheduled IASLC 2020 pharmamar.com ↗
This combination of lurbinectedin and irinotecan demonstrated efficacy in SCLC after failure of first-line therapy, including “remarkable activity in patients with resistant disease (CTFI <90 days) and in the 3rd line setting”. |
| 2020-12-03 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals and PharmaMar Announce Results of ATLANTIS Phase 3 Study Evaluating Zepzelca™ in Combination with Doxorubicin for Patients with Small Cell Lung Cancer Following One Prior Platinum-containing Line jazzpharma.com ↗
Importantly, key secondary and subgroup analyses favored the lurbinectedin combination arm. |
| 2020-06-15 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer jazzpharma.com ↗
Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. |
| 2020-02-19 | Luye Pharma Group Ltd. | Regulatory 绿叶制药合作创新药Lurbinectedin(Zepsyre®)获美国FDA优先审评资格 luye.com ↗ |
| 2020-02-17 | Jazz Pharmaceuticals | Regulatory PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer jazzpharma.com ↗
The FDA has set a PDUFA target action date of August 16, 2020 . |
All press releases naming this drug 108 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 108 releases opens the full record — a long page | ||
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lurbinectedin | “This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer.” PMID 30240327 ↗ Sep 201860“PURPOSE: Lurbinectedin (PM01183) binds covalently to DNA and has broad activity against tumor cell lines.” PMID 24563480 ↗ Feb 2014 “Lurbinectedin (PM01183)” NCT01831089 ↗ |
| Known as | Lurbinectedina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | Lurbinectedine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | PM-1183 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | PM01183 | “This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer.” PMID 30240327 ↗ Sep 201818“lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.” NCT01970540 ↗ “lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.” NCT01980667 ↗ “Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients” NCT02421588 ↗ “lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion” NCT02451007 ↗ “Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors” NCT05063318 ↗ “lurbinectedin (PM01183) 1 mg and 4 mg vials” NCT02210364 ↗ “Lurbinectedin (PM01183) for Injection” NCT04638491 ↗ “Drug: Lurbinectedin (PM01183)” NCT02566993 ↗ “Drug: Lurbinectedin (PM01183)” NCT01951157 ↗ “lurbinectedin (PM01183)” NCT01970553 ↗ |
| Known as | Tryptamicidin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | Zepsyre | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | Zepzelca | “A Phase II Pilot Clinical Trial of Lurbinectedin (Zepzelca™ PM01183) in Patients With Gastrointestinal Malignancies With DNA Repair Mutations” NCT05229588 ↗1“Lurbinectedin 4 MG Injection [Zepzelca]” NCT07121478 ↗ |
| Action | Inhibit | “a selective inhibitor of active transcription of protein-coding genes” PMID 30240327 ↗ Sep 2018 |
| Modality | Other / unclassified | “Lurbinectedin is in a class of medications called alkylating agents.” NCT04607954 ↗ |
| Route | Intravenous | “PM01183 administered every three weeks intravenously (i.v.) over one hour” NCT00877474 ↗ |