MEI Pharma and Kyowa Kirin Release Regulatory Update

Mar 25, 2022 By MarketDepth

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MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. have provided a regulatory update after a recent meeting with the U.S. Food Drug Administration to discuss marketing authorization for zandelisib, a phosphatidylinositol-3-kinase inhibitor drug candidate.  “The FDA’s current position on the assessment of benefit and risk of PI3K inhibitors solely based on single arm studies appears to have evolved, as evidenced by the position the FDA communicated at the recent meeting on zandelisib, and the upcoming ODAC meeting scheduled for April 21, 2022 to discuss whether randomized data should be required for the class of PI3K inhibitors to demonstrate appropriate evidence of efficacy and safety,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “Clearly, the outcome of our recent FDA meeting is a disappointing development. Nonetheless we will continue to focus on the ongoing Phase 3 COASTAL study as we consider options that provide the most expeditious approval pathway utilizing randomized data, and which we believe will demonstrate the potential of zandelisib to help patients. Today’s announcement in no way diminishes our conviction to the development of zandelisib and the promise of its emerging clinical profile. Based on current projections, MEI believes we have sufficient cash for operations to complete the COASTAL study enrollment in 2024.”

“In partnership with Kyowa Kirin, we remain committed to the ultimate potential of zandelisib to address important medical needs as a single agent or in combination with other therapies providing physicians, and their patients, important new treatment options. We plan on completing evaluation of the Phase 2 TIDAL study, and look forward to sharing final data later this year to further advance an understanding of zandelisib’s clinical utility.”

Daniel P. Gold, Ph.D., President and CEO of MEI Pharma

“Our dialogue with the FDA has updated our understanding of the evolving regulatory view of the PI3K inhibitor drug class. With this knowledge, we can focus our efforts to advance the COASTAL program,” said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D of Kyowa Kirin. “Our teams around the world have made steady progress to enroll patients and give us important momentum. Together with MEI Pharma, we will continue to work with the investigators, patients, and advocacy organizations to drive continued progress.”