The program will be made available to eligible patients in the U.S. and selected European countries diagnosed with relapsed or refractory acute myeloid leukemia (AML) and will be managed by Clinigen Group’s Idis Managed Access division.
“Sunesis is committed to providing patients and healthcare providers around the globe with more options for treating relapsed and refractory AML, a disease for which the standard of care has changed little in the last four decades,” said Parvinder Hyare, vice president of global oncology operations at Sunesis.Vosaroxin is an investigational treatment and currently is not approved for use by any regulatory agency. Compassionate use programs are put in place to provide access to medicines for patients who have serious, or immediately life-threatening illnesses, and for whom no alternative treatment options are available. Access is provided in response to an unsolicited request from a physician for his or her patient with an unmet medical need.
Simon Estcourt, managing director of Idis Managed Access, said, “AML is the most common acute leukemia affecting adults, with a very low survival rate, so there is a real need for new treatment options in these patients. By using our global logistical and regulatory expertise, we will work with Sunesis and the AML community to provide ethical access to vosaroxin to help eligible patients who have no alternative treatment options.”
