MEI Pharma and Kyowa Kirin have announced plans to discontinue the international development of investigational cancer therapy, zandelisib, for B-cell malignancies outside of Japan.
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.
MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced the grant of inducement stock options for an aggregate of 18,000 shares of the company’s common stock to one new employee. The stock options were granted as a material inducement to the new employee accepting employment with MEI in accordance with Nasdaq Listing Rule 5635(c)(4).
An experimental lymphoma drug from MEI Pharma and Kyowa Kirin must undergo further testing before the Food and Drug Administration will review it for approval, the companies said Thursday. They had aimed to win an accelerated FDA clearance for the drug, called zandelisib, based on Phase 2 data showing the drug reduced or eliminated signs of cancer.
SAN DIEGO & TOKYO--(BUSINESS WIRE)--MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), today provided an update after a recent meeting with the U.S. Food Drug Administration (FDA) to discuss the pursuit of a marketing authorization for zandelisib, a phosphatidylinositol-3-kinase (“PI3K”) inhibitor drug candidate, via the accelerated approval pathway under 21 CFR Part 314.500, Subpart H, based on data generated by the single arm Phase 2 TIDAL study. In the meeting, the FDA informed the companies of its position that a randomized trial is now needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib. Based on this view, the agency discouraged a filing based on the Phase 2 TIDAL study data and emphasized that the companies continue efforts with the ongoing, randomized Phase 3 COASTAL study as planned. Accordingly, in line with the FDA’s recommendation, the companies do not plan to submit an FDA marketing application based on the single arm Phase 2 TIDAL study. In addition, while the FDA stated that safety on the 60 mg intermittent schedule appears reasonable, it recommended continued dose exploration to further support the current dose and regimen.
The pivotal trial linked zandelisib to a 70% response rate but leaves scope to question whether the drug can crack a competitive space.
SAN DIEGO & BEDMINSTER, N.J.--(BUSINESS WIRE)--MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that utilizes the latest biotechnology to discover and deliver novel medicines, today announced that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation (ODD) to zandelisib for the treatment of follicular lymphoma.