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Akademický článek

FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.

Autor: Mehta GU; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Vellanki PJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Ren Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Amatya AK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Mishra-Kalyani PS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Pan L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Zirkelbach JF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Pan Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Aungst SL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Miller CP; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Shah M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Rahman NA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Theoret M; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, United States., Kluetz P; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, United States., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, United States., Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, United States., Singh H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, United States.

Publikováno v: The oncologist [Oncologist] 2024 Aug 05; Vol. 29 (8), pp. 667-671.

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Akademický článek

Evaluation of somatic copy number variation detection by NGS technologies and bioinformatics tools on a hyper-diploid cancer genome.

Autor: Masood D; Office of Oncologic Diseases, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, 20993, USA., Ren L; State Key Laboratory of Genetic Engineering, Human Phenome Institute, School of Life Sciences and Shanghai Cancer Center, Fudan University, Shanghai, China., Nguyen C; Computational Genomics and Bioinformatics Branch, Center for Biomedical Informatics and Information Technology (CBIIT), National Cancer Institute, Rockville, MD, USA., Brundu FG; Illumina Inc., San Diego, CA, USA., Zheng L; Office of Oncologic Diseases, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, 20993, USA., Zhao Y; Sequencing Facility Bioinformatics Group, Biomedical Informatics and Data Science Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA., Jaeger E; Illumina Inc., San Diego, CA, USA., Li Y; Illumina Inc., San Diego, CA, USA., Cha SW; Illumina Inc., San Diego, CA, USA., Halpern A; Illumina Inc., San Diego, CA, USA., Truong S; Illumina Inc., San Diego, CA, USA., Virata M; Illumina Inc., San Diego, CA, USA., Yan C; Computational Genomics and Bioinformatics Branch, Center for Biomedical Informatics and Information Technology (CBIIT), National Cancer Institute, Rockville, MD, USA., Chen Q; Computational Genomics and Bioinformatics Branch, Center for Biomedical Informatics and Information Technology (CBIIT), National Cancer Institute, Rockville, MD, USA., Pang A; Bionano Genomics, San Diego, CA, 20892, USA., Alberto R; Bionano Genomics, San Diego, CA, 20892, USA., Xiao C; National Center for Biotechnology Information, National Librarssy of Medicine, National Institutes of Health, Bethesda, MD, 20892, USA., Yang Z; Center for Genomics, Loma Linda University School of Medicine, Loma Linda, CA, USA., Chen W; Center for Genomics, Loma Linda University School of Medicine, Loma Linda, CA, USA., Wang C; Center for Genomics, Loma Linda University School of Medicine, Loma Linda, CA, USA., Cross F Jr; Office of Oncologic Diseases, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, 20993, USA., Catreux S; Illumina Inc., San Diego, CA, USA., Shi L; State Key Laboratory of Genetic Engineering, Human Phenome Institute, School of Life Sciences and Shanghai Cancer Center, Fudan University, Shanghai, China., Beaver JA; Office of Oncologic Diseases, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, 20993, USA.; Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA., Xiao W; Office of Oncologic Diseases, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, 20993, USA. wenming.xiao@fda.hhs.gov., Meerzaman DM; Computational Genomics and Bioinformatics Branch, Center for Biomedical Informatics and Information Technology (CBIIT), National Cancer Institute, Rockville, MD, USA. meerzamd@mail.nih.gov.

Publikováno v: Genome biology [Genome Biol] 2024 Jun 20; Vol. 25 (1), pp. 163. Date of Electronic Publication: 2024 Jun 20.

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