The company plans to launch the drug, Daurismo, in the US by early December with a monthly list price of $16,925
The US Food and Drug Administration (US FDA) has approved Pfizer’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 US by early December with a monthly list price of $16,925, a Pfizer spokeswoman told Reuters.
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.
“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.