Amrubicin

Overview

Amrubicin is a third-generation synthetic anthracycline currently in development for the treatment of small cell lung cancer. Pharmion licensed the rights to Amrubicin in November 2006. In 2002, Amrubicin was approved and launched for sale in Japan based on Phase 2 efficacy data in both SCLC and NSCLC. Since January 2005, Amrubicin has been marketed by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of Amrubicin .

Indication

Investigated for use/treatment in lung cancer .

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC	2024/08/19	2023-509628-16-00	Phase 3	Recruiting	Daiichi Sankyo Inc.
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer	2023/02/23	NCT05740566	Phase 3	Active, not recruiting	Amgen
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer	2015/06/25	NCT02481830	Phase 3	Completed	Bristol-Myers Squibb
A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy	2013/07/22	NCT01904253	Phase 2	Terminated	Taiho Oncology, Inc.
A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies	2011/06/02	NCT01364727	Phase 2	Completed	Heather Wakelee
Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma	2011/05/18	NCT01355705	Phase 1	Completed	Michaela Liedtke
Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma	2011/04/08	NCT01331824	Phase 2	Terminated	Matthew Galsky
Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma	2010/12/14	NCT01259375	Phase 2	Completed	University of Utah
Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer	2010/09/22	NCT01207011	Phase 3	Completed	Sumitomo Pharma Co., Ltd.
A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer	2010/02/26	NCT01076504	Phase 2	Completed	SCRI Development Innovations, LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Phase 3 Trial of Ifinatamab Deruxtecan Launched for Relapsed Small Cell Lung Cancer

a year ago

• Daiichi Sankyo and Merck have initiated the IDeate-Lung02 Phase 3 trial to evaluate ifinatamab deruxtecan (I-DXd) versus chemotherapy in relapsed small cell lung cancer (SCLC). • The trial will assess the efficacy and safety of I-DXd, a potential first-in-class B7-H3 directed antibody-drug conjugate, in patients who have progressed after one prior line of platinum-based chemotherapy. • The primary endpoints of the study are objective response rate (ORR) and overall survival, with secondary endpoints including progression-free survival and duration of response. • Approximately 460 patients across multiple continents will be enrolled in the IDeate-Lung02 trial, with the aim of addressing the unmet need for effective treatments in relapsed SCLC.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access