Clinical review considerations of class I PI3K inhibitors in hematolymphatic malignancies by Center for Drug Evaluation

Limin Zou; Yueli Qi; Ling Tang; Yu Du; Meiyi Xiang; Xiaoming Chen; Jun Ma; Zhimin Yang

doi:10.21147/j.issn.1000-9604.2022.04.09

Clinical review considerations of class I PI3K inhibitors in hematolymphatic malignancies by Center for Drug Evaluation

Chin J Cancer Res. 2022 Aug 30;34(4):415-421. doi: 10.21147/j.issn.1000-9604.2022.04.09.

Authors

Limin Zou¹, Yueli Qi¹, Ling Tang¹, Yu Du¹, Meiyi Xiang¹, Xiaoming Chen², Jun Ma³, Zhimin Yang¹

Affiliations

¹ Office of Clinical Evaluation 1, Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
² Office of Management and Communication, Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
³ Harbin Institute of Hematology and Oncology, Harbin 150010, China.

PMID: 36199534
PMCID: PMC9468018
DOI: 10.21147/j.issn.1000-9604.2022.04.09

Abstract

Several phosphoinositide 3-kinase (PI3K) inhibitors are currently approved to treat hematolymphatic malignant diseases worldwide, and many drugs that have the same target are in the clinical research stage. In March 2022, duvelisib became the first PI3K inhibitor approved in China indicated for the treatment of hematolymphatic malignant diseases. Meanwhile, linperlisib and copanlisib have almost completed the technical review of the clinical specialty. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) found that class I PI3K inhibitors can cause various degrees of immune-related adverse events, which are associated with action mechanisms, affecting the benefit-risk assessment of the drugs. On April 21, 2021, the United States Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the safety of PI3K inhibitors indicated for hematolymphatic malignancies and their related risk of death. The hematological tumor group of CDE of the China NMPA summarized and combined the data on PI3K inhibitors listed or under technical review for marketing authorization applications and found that such products may have unique efficacy and safety characteristics in Chinese patients with malignant lymphoma.

Keywords: Class I PI3K inhibitors; efficacy; hematolymphatic malignancies; safety.