Clinigen partners with Sunesis to start compassionate use program for vosaroxin

The program has been initiated today and will be made available to eligible patients in the U.S. and selected European countries diagnosed with relapsed or refractory acute myeloid leukemia (AML).

Vosaroxin is an investigational treatment and is currently 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/her patient with an unmet medical need.

Clinigen Group managing director of Idis Managed Access Simon Estcourt 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."

Sunesis VP of global oncology operations Par Hyare said: "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.

"We are pleased to be working with Idis MA, a recognized leader in providing ethical access to medicines that address unmet needs and will be working towards gaining approval for vosaroxin in the U.S. and Europe for the treatment of relapsed and refractory AML."