FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma.

Miller, Barry W; Przepiorka, Donna; de Claro, R Angelo; Lee, Kyung; Nie, Lei; Simpson, Natalie; Gudi, Ramadevi; Saber, Haleh; Shord, Stacy; Bullock, Julie; Marathe, Dhananjay; Mehrotra, Nitin; Hsieh, Li Shan; Ghosh, Debasis; Brown, Janice; Kane, Robert C; Justice, Robert; Kaminskas, Edvardas; Farrell, Ann T; Pazdur, Richard

Miller, Barry W; Przepiorka, Donna; de Claro, R Angelo; Lee, Kyung; Nie, Lei; Simpson, Natalie; Gudi, Ramadevi; Saber, Haleh; Shord, Stacy; Bullock, Julie; Marathe, Dhananjay; Mehrotra, Nitin; Hsieh, Li Shan; Ghosh, Debasis; Brown, Janice; Kane, Robert C; Justice, Robert; Kaminskas, Edvardas; Farrell, Ann T; Pazdur, Richard.

Affiliation

Miller BW; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Barry.Miller@fda.hhs.gov.
Przepiorka D; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
de Claro RA; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Lee K; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Nie L; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Simpson N; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Gudi R; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Saber H; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Shord S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Bullock J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Marathe D; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Mehrotra N; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Hsieh LS; Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Ghosh D; Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Brown J; Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kane RC; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Justice R; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kaminskas E; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Farrell AT; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Pazdur R; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Clin Cancer Res ; 21(7): 1525-9, 2015 Apr 01.

Article de En | MEDLINE | ID: mdl-25645861

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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Purines / Leucémie chronique lymphocytaire à cellules B / Lymphome folliculaire / Quinazolinones / Phosphatidylinositol 3-kinases de classe I / Antinéoplasiques Limites: Humans Langue: En Journal: Clin Cancer Res Sujet du journal: NEOPLASIAS Année: 2015 Type de document: Article Pays de publication: États-Unis d'Amérique

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