Idelalisib is under clinical development by Gilead Sciences and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma). According to GlobalData, Phase II drugs for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Idelalisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Idelalisib (Zydelig) drug belongs to anti-neoplastic agent. It is formulated as film-coated tablets for oral route of administration. Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. Zydelig in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities, for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies.
The drug candidate is under development for waldenstrom macroglobulinemia, non-small cell lung cancer and diffuse large B-cell lymphoma, follicular lymphoma.
The drug candidate was also under development for indolent B-cell non-Hodgkin lymphomas including small lymphocytic lymphoma, follicular lymphoma, lymphoblastic lymphoma, marginal zone lymphoma, mantle cell lymphoma and frontline chronic lymphocytic leukemia, mediastinal B-cell lymphoma and metastatic pancreatic ductal adenocarcinoma, primary myelofibrosis, post-essential thrombocythemia myelofibrosis, post-polycythemia vera myelofibrosis (PPV-MF), polycythemia vera,nodal marginal zone B-Cell lymphoma, extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue or malt-lymphoma), splenic marginal zone B-cell lymphoma, refractory and relapsed chronic lymphocytic leukemia.
Gilead Sciences overview
Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer, and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.
For a complete picture of Idelalisib’s drug-specific PTSR and LoA scores, buy the report here.