Pfizer gets FDA green light for Daurismo
The Food and Drug Administration gave its blessing to Pfizer’s Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, or LDAC, a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia, or AML in adults who are 75 years old or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy.
"Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today's approval gives healthcare providers another tool to use in the treatment of AML patients with various, unique needs," said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy."
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow.
The National Cancer Institute at the National Institutes of Health estimates that in 2018, approximately 19,520 people will be diagnosed with AML, and approximately 10,670 patients with AML will die of the disease. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities.
The FDA granted this application Priority Review designation.
Daurismo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
"Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today's approval gives healthcare providers another tool to use in the treatment of AML patients with various, unique needs," said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy."
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow.
The National Cancer Institute at the National Institutes of Health estimates that in 2018, approximately 19,520 people will be diagnosed with AML, and approximately 10,670 patients with AML will die of the disease. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities.
The FDA granted this application Priority Review designation.
Daurismo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.