The companies noted that men taking MDV3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo (p < 0.0001; HR=0.631).
MDV3100 surpassed the study's team expectations in the AFFIRM trial by meeting the primary and secondary endpoints with strong statistical significance and demonstrating a favourable safety profile, said Dr Howard Scher, chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the AFFIRM trial.
Medtronic seeks expanded US approvals for Hugo robotic surgery system
MiniMed expands Abbott partnership for dual glucose-ketone diabetes sensors
Lupin and Natco secure US FDA approval for generic Eribulin Mesylate Injection
Luminopia agrees international licensing deal for paediatric amblyopia treatment in Japan
FDA accepts Genentech's giredestrant application for early-stage breast cancer
Amgen receives EU marketing authorisation for IMDYLLTRA in ES-SCLC
Haisco receives US FDA approval for anaesthetic Cipepofol
Hanmi signs licensing deal with Lilly for sonefpeglutide
FDA approves TREMFYA label expansion
GSK reports positive phase III data for bepirovirsen in chronic hepatitis B
Sanofi's venglustat receives FDA priority review for type 3 Gaucher disease
CellCarta partners with Sonic Healthcare to commercialise companion diagnostics through Lab Network
Ribo submits Phase 2 trial application for RBD1119 to European regulator
US FDA extends review timeline for AstraZeneca's camizestrant application
Orsini to chosen as contracted specialty pharmacy for Gilead's Hepcludex (bulevirtide-gmod)