Bayer's PI3Kα/δ Dual Inhibitor Copanlisib Approved in China for Relapsed or Refractory Follicular Lymphoma

On May 23, the NMPA approved Bayer's PI3K inhibitor Copanlisib Hydrochloride for Injection for marketing, intended for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Copanlisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor administered via intravenous injection, which exhibits inhibitory activity against both PI3K-α and PI3K-δ subtypes expressed in malignant B cells, inducing tumor cell death through apoptosis and the suppression of malignant B cell proliferation.

Mechanism of Action of Copanlisib: Dual Inhibition of PI3K-α and PI3K-δ Kinase Subtypes, Blocking Signal Transduction

Copanlisib was approved by the FDA in September 2017 for the treatment of patients with relapsed follicular lymphoma (FL) who have received at least two prior lines of therapy. The accelerated approval for this indication was based on the results of the open-label, single-arm Phase II CHRONOS-1 study, which demonstrated an overall response rate (ORR) of 59% in patients, with a complete response (CR) rate of 14%. Updated results after two years of follow-up showed that the ORR in the FL population was 59%, with a CR rate of 20%.

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