Kaiser MF, Cliff ERS - Journal of Clinical Oncology
Venetoclax (Venclexta) demonstrated early, biologically coherent activity in t(11;14) myeloma, but an all‑comer phase 3 strategy produced safety concerns and regulatory freezes that ultimately blocked access even for likely responders. Drug development and regulatory pathways must better accommodate strong biological signals in small subgroups to avoid repeating failures that strand effective therapies.
VIEW SOURCE
Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics
Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics
Eisenkraft Klein D, Kesselheim AS - Health Policy