The U.S. Food and Drug Administration on Wednesday approved Pfizer Inc’s drug to treat a form of blood cancer in newly diagnosed patients as a combination therapy.
Pfizer plans to launch the drug, Daurismo, in the United States by early December with a monthly list price of $16,925, a Pfizer spokeswoman told reporters.
Daurismo was approved for use in adults with acute myeloid leukemia (AML) aged 75 or older or those who have certain health conditions prior to receiving their diagnosis, for whom intensive chemotherapy is not an option, Pfizer said.
The treatment comes with a boxed warning – the agency’s harshest – that flags risks of severe birth defects or embryo-fetal death, reports Reuters.
“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence.
Daurismo along with low-dose chemotherapy improved overall survival in clinical trials, when compared to treatment with only low-dose chemotherapy.
Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of serious side effects and chemotherapy-related toxicities, the FDA said.
The American Cancer Society has estimated that there would be about 19,520 new cases of AML, a rapidly progressing cancer that forms in the bone marrow, in the United States this year.
The FDA earlier in the day also approved Roche-AbbVie’s Venclexta combination therapy for AML.