Pharmion Corporation announced that it has received full approval from the US FDA to market Vidaza for the treatment of Myelodysplastic Syndromes (MDS).
The FDA approved Vidaza for treatment of all five MDS subtypes. These subtypes include: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pharmion intends to make Vidaza commercially available within several weeks.
"The approval of Vidaza represents a significant milestone for Pharmion and, more importantly, represents an important new option for patients being treated for Myelodysplastic Syndromes," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "Until today, there have been no approved therapies for the treatment of MDS. We are proud to have advanced the work of the National Cancer Institute, the Cancer and Leukemia Group B (CALGB) and other academic institutions and clinicians to the point that this drug can now be commercially available to treat this very serious and life- threatening disease."
MDS is a bone marrow disorder characterized by the production of abnormally functioning, immature blood cells. The highest prevalence of MDS is in patients over 60 years of age. According to the American Cancer Society and the Aplastic Anemia and MDS International Foundation, there are an estimated 10,000-30,000 new cases of MDS in the United States each year. Survival rates range from six months to many years for the different subtypes of MDS. MDS can result in death from bleeding and infection in the majority of patients, and transformation to acute myelogenous leukemia (AML) occurs in up to 40 percent of patients. The prognosis for patients transforming to AML is exceptionally poor.
"The CALGB is proud to have conducted the pivotal clinical trials involved in the development of Vidaza," said Dr. Richard L. Schilsky, professor of medicine and associate dean for clinical research at the University of Chicago and chairman of the CALGB. "We are delighted to have had the opportunity to work with Pharmion and to now see Vidaza move from an experimental therapy to an approved product. Most importantly, we believe the approval of Vidaza is an important step forward for patients with MDS."