Discontinuation of Zandelisib Development Outside of Japan Following Recent FDA Meeting announced
“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.”
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