Zepzelca® (lurbinectedin) and Tecentriq Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage SCLC June 17, 2025
MAA submitted to the EMA for Zepzelca® (lurbinectedin) + Tecentriq for the maintenance treatment of adult patients with ES-SCLC May 27, 2025
U.S. FDA granted Fast Track Designation for ZL-1310 for Treatment of Extensive-Stage SCLC May 21, 2025
Ph 3 DeLLphi-304 trial of IMDELLTRA (tarlatamab-dlle) in SCLC patients met primary endpoint at a planned interim analysis April 16, 2025
Plans announced for Ph 2 trial of stenoparib + temozolomide for the treatment of recurrent SCLC March 11, 2025
US FDA Grants Orphan Drug Designation to 225Ac-SSO110 (satoreotide) for the treatment of patients with SCLC February 11, 2025
Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of SCLC January 28, 2025
FDA Clears 225Ac-Satoreotide Ph 1/2 Clinical Study in Patients with SCLC or Merkel Cell Carcinoma January 21, 2025
Asher Bio Announces Clinical Trial Collaboration & Supply Agreement on Etakafusp Alfa (AB248) in Combination with Bispecific T-cell Engager in SCLC Patients January 15, 2025
FDA clears IND for Ph 1/2 clinical trial of REC-4539 in SCLC and MHRA clears IND for Ph 1 clinical trial of REC-3565 for B-cell malignancies January 15, 2025
IDEAYA Biosciences Enters Exclusive License with Hengrui Pharma for SHR-4849 Targeting SCLC and NET Solid Tumors December 31, 2024
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for 2L Treatment of ES-SCLC December 26, 2024
ZL-1310 Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage SCLC October 29, 2024
Positive and Statistically Significant OS and PFS Results for Zepzelca® (lurbinectedin) & Atezolizumab Combo in 1L Maintenance Therapy for ES-SCLC October 22, 2024
Ifinatamab Deruxtecan Continues to Demonstrate Promising ORR in Patients with Extensive-Stage SCLC in IDeate-Lung01 Ph 2 Trial September 10, 2024
FDA grants Breakthrough Therapy Designation to GSK5764227 for R/R extensive-stage SCLC August 27, 2024
Imfinzi granted Priority Review and Breakthrough Therapy Designation for patients with limited-stage SCLC in the US August 22, 2024
