FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.

Autor: Agrawal S; United States Food and Drug Administration, Silver Spring, MD, United States., Lee C; United States Food and Drug Administration, Silver Spring, Maryland, United States., Pierce WF; Food and Drug Administration, Silver Spring, Maryland, United States., Everhart E; United States Food and Drug Administration, Silver Spring, MD, United States., King-Ducre A; Food and Drug Administration, Silver Spring, Maryland, United States., Royce M; United States Food and Drug Administration, Silver Spring, Maryland, United States., Osgood CL; United States Food and Drug Administration, Silver Spring, MD, United States., Amiri-Kordestani L; Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, United States., Chiu HJ; Food and Drug Administration, Silver Spring, Maryland, United States., Ricks TK; United States Food and Drug Administration, Silver Spring, MD, United States., Pan L; United States Food and Drug Administration, Silver Spring, Maryland, United States., Fourie Zirkelbach J; United States Food and Drug Administration, Silver Spring, Maryland, United States., Charlab R; United States Food and Drug Administration, Silver Spring, MD, United States., Pacanowski M; United States Food and Drug Administration, Silver Spring, MD, United States., Kim T; United States Food and Drug Administration, Silver Spring, MD, United States., Pazdur R; United States Food and Drug Administration, Silver Spring, MD, United States., Kluetz PG; Food and Drug Administration, Silver Spring, MD, United States., Gao JJ; United States Food and Drug Administration, Silver Spring, MD, United States.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Oct 08. Date of Electronic Publication: 2024 Oct 08.

US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

Autor: Heiss BL; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Chang E; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Gao X; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Truong T; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Brave MH; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Bloomquist E; Merck & Co, Rahway, NJ., Shah A; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Hamed S; Astellas Pharma, Tokyo, Japan., Kraft J; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Chiu HJ; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Ricks TK; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Tilley A; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Pierce WF; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Tang L; Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD., Abukhdeir A; AstraZeneca, Cambridge, United Kingdom., Kalavar S; Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD., Philip R; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD., Tang S; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Pazdur R; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD., Amiri-Kordestani L; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Kluetz PG; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD., Suzman DL; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Publikováno v: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 May 20; Vol. 42 (15), pp. 1851-1860. Date of Electronic Publication: 2024 Mar 07.

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Autor: Gao JJ; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Osgood CL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Feng Z; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Bloomquist EW; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chang CJG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hou SC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Rivera DR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 Dec 15; Vol. 29 (24), pp. 5008-5011.

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer.

Autor: Fallah J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Agrawal S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gittleman H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Subramaniam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., John C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Niu G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fotenos A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chiang K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Suzman DL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 May 01; Vol. 29 (9), pp. 1651-1657.

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

Autor: Royce M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Osgood CL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Amatya AK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chang CJG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Shetty KA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kraft J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., King KE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Rastogi A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Janelsins B; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Weinberg WC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Clouse K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Borders-Hemphill V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Brown L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gomez-Broughton C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li Z; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Nguyen TT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu Z; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ly AT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gao T; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tu CM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., King-Kallimanis B; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chiang K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lee C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Leighton JK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Apr 14; Vol. 28 (8), pp. 1487-1492.