News >

FDA Grants Lurbinectedin Orphan Drug Status for SCLC

Jason M. Broderick @jasoncology
Published: Monday, Aug 06, 2018

Luis Mora Capitan
Luis Mora Capitan
The FDA has granted lurbinectedin (PM1183) an orphan drug designation for the treatment of patients with small cell lung cancer (SCLC), according to PharmaMar, the manufacturer of the marine-derived treatment.

Lurbinectedin is currently being studied in the global, randomized, phase III ATLANTIS study with doxorubicin versus investigator’s choice of either cyclophosphamide, doxorubicin and vincristine or topotecan (NCT02566993). ATLANTIS is actively recruiting for patients with SCLC who have failed 1 prior platinum-containing line of therapy.
Perez JMT, Leary A, Besse B, et al. Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study. J Clin Oncol. 2018;36 (suppl; abstr 8570).

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Working Group for Changing Standards in EGFR-Mutated Lung Cancers: Real-World Applications of the Evidence for NursesJun 29, 20191.5
Oncology Briefings™: Current Perspectives on Preventing and Managing Tumor Lysis SyndromeJun 30, 20191.0
Publication Bottom Border
Border Publication