It has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Regulatory history
Follicular lymphoma
For follicular lymphoma, the FDA awarded copanlisib orphan drug status in February 2015 and fast track designation in February 2016. The NDA for follicular lymphoma was granted priority review in May 2017.In September 2017, it received accelerated approval (FDA regulation 21 CFR Part 314 subpart H) for the treatment of adult patients experiencing relapsed follicular lymphoma who have received at least two prior systemic therapies. Further clinical trials are to be performed as a post-marketing requirement to verify the clinical benefit. Other
Copanlisib was granted orphan drug status for the treatment of splenic, nodal and extranodal subtypes of marginal zone lymphoma. Clinical trials
Phase II clinical trials are in progress for treatment of endometrial cancer, diffuse large B-cell lymphoma, cholangiocarcinoma, and non-Hodgkin lymphoma. Copanlisib in combination with R-CHOP or R-B (rituximab and bendamustine) is in a phase III trial for relapsed indolent non-Hodgkin lymphoma (NHL). Two separate phase III trials are investigating the use of copanlisib in combination with rituximab for indolent NHL and the other using copanlisib alone in cases of rituximab-refractory indolent NHL.In a preclinical study, copanlisib was effective in inhibiting HER2+ breast cancer cells with acquired resistance to the HER2-inhibitors trastuzumab and/or lapatinib. This effect was increased when copanlisib was administered along with the aforementioned HER2-inhibitors. Consequently, treatments of copanlisib with trastuzumab are being clinically trialled in HER2-positive breast cancer patients. == References ==
U.S. National Library of Medicine.