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Phase III Lung Cancer Trial Stopped Early Due to Significant Survival Improvement
americanpharmaceuticalreview
April 29, 2020
Regeneron and Sanofi announced the primary endpoint of overall survival (OS) was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo? (cemiplimab).
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Expanded EU approval for Takeda's Alunbrig
pharmatimes
April 10, 2020
European regulators have expanded the scope of Alunbrig (brigatinib) to include its use as a monotherapy for the treatment of adults with anaplastic lymphoma kinase-positive (ALK+) ...
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Expanded EU approval for Takeda's Alunbrig
pharmatimes
April 08, 2020
European regulators have expanded the scope of Alunbrig (brigatinib) to include its use as a monotherapy for the treatment of adults with anaplastic lymphoma kinase-positive (ALK+) ...
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TEPMETKO? (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations
prnasia
March 25, 2020
Merck, a leading science and technology company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved TEPMETKO?* (tepotinib) for the treatment of patients with unresectable, advanced or recurrent non-small cell lung
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J&J NSCLC Drug Gets Breakthrough Designation
contractpharma
March 12, 2020
Bispecific antibody targets activating and resistant EGFR and MET mutations and amplifications in non-small cell lung cancer.
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NCCN, AstraZeneca Announce Lung Cancer Projects
americanpharmaceuticalreview
March 05, 2020
The National Comprehensive Cancer Network? (NCCN?) Oncology Research Program (ORP) announced three research projects selected to receive funding to improve healthcare provider performance ...
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BMS secures FDA priority review for NSCLC treatment combination
pharmaceutical-technology
January 17, 2020
Bristol-Myers Squibb Company (BMS) has secured the US Food and Drug Administration (FDA) priority review for a drug combination to treat metastatic or recurrent non-small cell lung cancer (NSCLC).
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Blueprint Announces Top-line Data for Pralsetinib, Initiates Rolling NDA Submission
americanpharmaceuticalreview
January 14, 2020
Blueprint Medicines announced independent centrally reviewed top-line data for pralsetinib in patients with RET fusion-positive non-small cell lung cancer (NSCLC).
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BMI, Survival Linked in NSCLC Treated With Atezolizumab
drugs
December 30, 2019
Baseline high body mass index (BMI) is associated with improved survival in patients with non-small cell lung cancer (NSCLC) treated with atezolizumab ...
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OSE Immunotherapeutics, HalioDx Announce Lung Cancer Study Collaboration
americanpharmaceuticalreview
December 30, 2019
OSE Immunotherapeutics and HalioDx announced a collaboration to conduct a translational investigation of immune biomarkers as part of the ongoing Phase 3 clinical trial of ...