[ad_1]
SAN DIEGO & TOKYO–(BUSINESS WIRE)–MEI Pharma, Inc. (Nasdaq: MEIP), a pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a Japan-based global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, today announced that after receiving the most recent guidance from a late November meeting with the U.S. Food and Drug Administration (FDA), the companies are discontinuing global development of zandelisib outside of Japan for B-cell malignancies. Kyowa Kirin is continuing the ongoing clinical trials including Phase 2 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.”
“We share MEI’s disappointment in making this decision,” said Yoshifumi Torii, Ph.D., executive officer, vice president, head of R&D division of Kyowa Kirin. “However, given the Phase 2 data we previously announced on zandelisib, we still see potential to continue the program in Japan to address unmet patient…
..
[ad_2]
