Research & Development
Verastem Oncology submits Marketing Authorization Application to European Medicines Agency for COPIKTRA for cancer patients
25 November 2019 -

Biopharmaceutical company Verastem Inc (Nasdaq:VSTM) reported on Monday that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K).

COPIKTRA has been developed for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).

Brian Stuglik, chief executive officer of Verastem Oncology, stated: "We have seen the significant benefit of COPIKTRA as a treatment option for patients throughout our clinical trials and experience globally." He added; "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."

Verastem Oncology stated that it is committed to the development and commercialisation of medicines to improve the lives of patients diagnosed with cancer. The company's first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin's lymphoma (iNHL) and its pipeline is comprised of product candidates that seek to treat cancer by modulating the local tumour microenvironment.

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