Hutchmed has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin’s lymphoma (NHL).
Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA). This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients’ unmet needs more quickly.
Christian Hogg, CEO of Hutchmed, said: “The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor. There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes. We look forward to important clinical data on amdizalisib being presented at the ESMO Congress next week and are continuing to accelerate global development of this novel therapy.”
Updated preliminary results from the ongoing Phase Ib expansion study in China will be presented as a Proffered Paper at the 2021 European Society for Medical Oncology (ESMO) Congress on September 20, 2021. To date, amdizalisib has been shown to be well tolerated, exhibiting dose-proportional pharmacokinetics (PK), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients.
Hutchmed has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In April 2021, HUTCHMED initiated a Phase II registration study in China for amdizalisib in approximately 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma (MZL). The trial is being conducted in over 35 sites in China.
Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the US and Europe in patients with relapsed or refractory NHL (NCT03786926).
Image credit: Myriam Zilles