Henlius' anti-PD-1 mAb MRCT achieved 15.38 months OS in first-line treatment of SCLC, reducing the risk of death by 38% of the overall population
Shanghai Henlius Biotech, Inc. (2696.HK) successfully held its Global R&D Day themed "H-evolution: From Biotech to Biopharma", and released its interim analysis results of Phase 3 clinical study (ASTRUM-005)...
December 21, 2021
by prnasia
Imfinzi Approved in China for Small Cell Lung Cancer
AstraZeneca’s Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of ...
July 20, 2021
by americanpharmaceuticalreview
Imfinzi Recommended for Approval by CHMP for Small Cell Lung Cancer
AstraZeneca’s Imfinzi (durvalumab) has been recommended for marketing authorization in the European Union (EU) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies ...
August 3, 2020
by americanpharmaceuticalreview
FDA Grants Accelerated Approval Metastatic Small Cell Lung Cancer Treatment
The Food and Drug Administration (FDA) has granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
June 29, 2020
by americanpharmaceuticalreview
Jazz' small cell lung cancer therapy wins US green light
Jazz Pharmaceuticals and PharmaMar have announced US approval of Zepzelca (lurbinectedin) for the treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
June 17, 2020
by pharmatimes
FDA approves Imfinzi for extensive-stage SCLC
AstraZeneca has announced that Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) as 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).
April 1, 2020
by pharmatimes
Imfinzi, tremelimumab combo flunks SCLC trial
AstraZeneca has released new high-level data from the final analysis of the Phase III CASPIAN trial, showing that the addition of the anti-CTLA4 antibody tremelimumab ...
March 19, 2020
by pharmatimes
AbbVie Discontinues Rova-T Research and Development Program
Phase 3 trial evaluating Rova-T as a first-line therapy for SCLC demonstrated no survival benefit for patients.
August 30, 2019
by contractpharma
FDA grants Orphan Drug Designation to Imfinzi for SCLC
The FDA has announced Orphan Drug Designation for Imfinzi (durvalumab) to treat small cell lung cancer in combination with other therapies.
July 16, 2019
by europeanpharmaceuticalreview
AbbVie halts phase III TAHOE trial of Rova-T for SCLC
Following advice from an independent data monitoring committee, biopharma company AbbVie has ceased enrolment in its TAHOE trial evaluating Rovalpituzumab Tesirine.....
December 10, 2018
by pharmaceutical-technology
BMS' Opdivo+Yervoy combo fails in small cell lung cancer
Bristol-Myers Squibb has revealed that its combo comprising Opdivo (nivolumab) and Yervoy (ipilimumab) failed to meet its primary endpoint as a maintenance treatment for extensive-stage
November 28, 2018
by pharmafile
KOL Views: How does Opdivo’s stumble shift the balance of power in SCLC?
KOL Views Imfinzi Keytruda Opdivo Tecentriq AstraZeneca BMS Merck & Co. Roche EMA FDA Lung Cancer Pulmonary/Respiratory Medicine Marketing & Sales Medical Affairs
October 17, 2018
by biospectrumasia