Discontinuation is announced of zandelisib development for B-cell malignancies, outside of Japan, following FDA Meeting.- MEI Pharma + Kyowa Kirin Co., Ltd.

Kyowa Kirin is continuing the ongoing clinical trials including Phase II MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas and will explore the potential for a submission to Japanese health authorities based on data from the MIRAGE and TIDAL clinical trials.

“Based on the most recent guidance received from the FDA at a late November meeting, we have jointly decided with Kyowa Kirin to discontinue development of zandelisib outside of Japan. We are very disappointed to share this decision in light of our belief in the potential of zandelisib to benefit patients and meet the ongoing need for new options to treat relapsed or refractory indolent non-Hodgkin lymphomas,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “However, in light of FDA’s guidance, we no longer believe clinical development can be completed within a time period that would support further investment, or with sufficient certainty of the regulatory requirements to justify continued global development efforts.”