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Lisa A Raedler
No abstract text is available yet for this article.
March 2015: American Health & Drug Benefits
G Kumar, T D Morton, A Padhiar, R Marsh, R Perard
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Qingshan Yang, Prexy Modi, Terry Newcomb, Christophe Quéva, Varsha Gandhi
Idelalisib [Zydelig (Gilead Sciences, Inc.), also known as CAL-101 and GS-1101] was approved in 2014 in the United States and European Union for the treatment of three indolent B-cell neoplasms: relapsed/refractory chronic lymphocytic leukemia (CLL, in combination with rituximab), relapsed follicular lymphoma, and relapsed small lymphocytic lymphoma (as monotherapy). Furthermore, it was approved in the European Union as first-line therapy for poor-prognosis CLL with 17p deletions or TP53 mutations and in patients unsuitable for chemoimmunotherapy...
April 1, 2015: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Barry W Miller, Donna Przepiorka, R Angelo de Claro, Kyung Lee, Lei Nie, Natalie Simpson, Ramadevi Gudi, Haleh Saber, Stacy Shord, Julie Bullock, Dhananjay Marathe, Nitin Mehrotra, Li Shan Hsieh, Debasis Ghosh, Janice Brown, Robert C Kane, Robert Justice, Edvardas Kaminskas, Ann T Farrell, Richard Pazdur
On July 23, 2014, the FDA granted accelerated approval to idelalisib (Zydelig tablets; Gilead Sciences, Inc.) for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. In a multicenter, single-arm trial, 123 patients with relapsed indolent non-Hodgkin lymphomas received idelalisib, 150 mg orally twice daily. In patients with follicular lymphoma, the overall response rate (ORR) was 54%, and the median duration of response (DOR) was not evaluable; median follow-up was 8...
April 1, 2015: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Gillian M Keating
Idelalisib (Zydelig®) is a first-in-class, orally administered, phosphatidylinositol 3-kinase-δ inhibitor that was recently approved for the treatment of relapsed chronic lymphocytic leukaemia (CLL), relapsed follicular B-cell non-Hodgkin's lymphoma (NHL) and relapsed small lymphocytic lymphoma (SLL) in the USA and for the treatment of CLL and refractory follicular lymphoma in the EU. In a pivotal phase III trial in patients with relapsed CLL who were not able to receive cytotoxic agents, recipients of idelalisib plus rituximab had significantly improved progression-free survival, overall survival, overall response and lymph node response, compared with recipients of placebo plus rituximab...
March 2015: Targeted Oncology
John R Somoza, David Koditek, Armando G Villaseñor, Nikolai Novikov, Melanie H Wong, Albert Liclican, Weimei Xing, Leanna Lagpacan, Ruth Wang, Brian E Schultz, Giuseppe A Papalia, Dharmaraj Samuel, Latesh Lad, Mary E McGrath
Idelalisib (also known as GS-1101, CAL-101, IC489666, and Zydelig) is a PI3Kδ inhibitor that has recently been approved for the treatment of several hematological malignancies. Given its use in human diseases, we needed a clear picture of how idelalisib binds to and inhibits PI3Kδ. Our data show that idelalisib is a potent and selective inhibitor of the kinase activity of PI3Kδ. A kinetic characterization clearly demonstrated ATP-competitive inhibition, and several additional biochemical and biophysical assays showed that the compound binds reversibly and noncovalently to the kinase...
March 27, 2015: Journal of Biological Chemistry
Kunj Gohil
Idelalisib (Zydelig) for certain types of leukemia and lymphoma, peginterferon beta-1a (Plegridy) for relapsing forms of multiple sclerosis, and suvorexant (Belsomra) for insomnia.
October 2014: P & T: a Peer-reviewed Journal for Formulary Management
Anthony Markham
Idelalisib (Zydelig(®)) is a highly specific small-molecule phosphatidylinositol-3-kinase (PI3Kδ) inhibitor that has been developed as an oral treatment for B cell haematological cancers.It has received its first approval in the US in July 2014 for the treatment of relapsed chronic lymphocytic leukaemia(CLL), relapsed follicular B-cell non-Hodgkin lymphoma(NHL) and relapsed small lymphocytic lymphoma (SLL) [corrected]. Idelalisib is under regulatory review in the EU-where it has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use-and in clinical development for CLL in Australia and Canada...
September 2014: Drugs
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