Verastem Oncology Announces Submission of a Marketing Authorization Application to the European Medicines Agency for COPIKTRA® (duvelisib)

On November 25, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), seeking approval for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL) (Press release, Verastem, NOV 25, 2019, View Source [SID1234551659]).

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"We have seen the significant benefit of COPIKTRA as a treatment option for patients throughout our clinical trials and experience globally," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The MAA submission for COPIKTRA in Europe is an important milestone in our mission to offer new therapies to patients in need and we are committed to working effectively with the EMA through the regulatory process to bring COPIKTRA to patients in Europe."