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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
prnasia
December 21, 2021
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)...
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Imfinzi Approved in China for Small Cell Lung Cancer
americanpharmaceuticalreview
July 20, 2021
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 ...
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Imfinzi Recommended for Approval by CHMP for Small Cell Lung Cancer
americanpharmaceuticalreview
August 03, 2020
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 ...
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FDA Grants Accelerated Approval Metastatic Small Cell Lung Cancer Treatment
americanpharmaceuticalreview
June 29, 2020
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.
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Jazz' small cell lung cancer therapy wins US green light
pharmatimes
June 17, 2020
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.
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FDA approves Imfinzi for extensive-stage SCLC
pharmatimes
April 01, 2020
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).
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Imfinzi, tremelimumab combo flunks SCLC trial
pharmatimes
March 19, 2020
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 ...
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AbbVie Discontinues Rova-T Research and Development Program
contractpharma
August 30, 2019
Phase 3 trial evaluating Rova-T as a first-line therapy for SCLC demonstrated no survival benefit for patients.
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FDA grants Orphan Drug Designation to Imfinzi for SCLC
europeanpharmaceuticalreview
July 16, 2019
The FDA has announced Orphan Drug Designation for Imfinzi (durvalumab) to treat small cell lung cancer in combination with other therapies.
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AbbVie halts phase III TAHOE trial of Rova-T for SCLC
pharmaceutical-technology
December 10, 2018
Following advice from an independent data monitoring committee, biopharma company AbbVie has ceased enrolment in its TAHOE trial evaluating Rovalpituzumab Tesirine.....