Topic: acute myeloid leukemia (AML)
Daiichi Sankyo went one for two in an FDA advisory committee doubleheader Tuesday, with its prospective leukemia treatment getting struck out.
The FDA has questioned the reliability of the phase 3 results Daiichi Sankyo hopes will win it approval for quizartinib in acute myeloid leukemia.
Daiichi’s PDUFA date for its FLT3 inhibitor has been pushed back to late August, as the FDA wants more time to review data from the Japanese pharma.
Swedish p53 cancer biotech Aprea Therapeutics has nabbed former Agios senior medical director Eyal Attar as its senior vice president and chief medical officer.
The FDA placed a partial clinical hold on a bispecific antibody in development for acute myeloid leukemia following reports of two patient deaths.
The funding will advance Vor's lead asset, an engineered hematopoietic stem cell therapy for acute myeloid leukemia.
Xospata won an FDA nod to treat relapsed or refractory acute myeloid leukemia patients with a FLT3 mutation.
Daurismo marked Pfizer's fourth FDA-approved NME oncology drug with in a two-month period.
Tibsovo won't be a blockbuster with peak sales hovering around the $300 million mark, but it’s still on the hook to treat around 700 to 1,100 AML patients with the IDH1 mutation in the U.S.
BMS and Eisai spinoff H3 Biomedicine will conduct research aimed at developing immune therapies for cancer using the latter’s RNA-splicing platform.