Pat Soon-Shiong, Chairman of Chan Soon-Shiong Family Foundation, Executive Chairman at ImmunityBio, and Executive Chairman of the Los Angeles Times, shared a post on X:
“It would be highly instructive to review how Merck and FDA agreed on approvals BASED ON SINGLE ARM TRIALS. See the package insert of June 2018 where five single-arm trials were combined for approval across multiple tumors (MSI-high).
See Table 25 & Table 27 on page 45 of Five single arm trials even with different doses and multiple tumor types sometimes with N=1 or N=2 in each tumor type. Rules for big pharma should apply to innovative biotech’s yes? More to come on rankings of immunotherapy molecules that can cure cancers (IL-15 versus Checkpoint inhibitors).
Merck’s Keytruda indication for MSI high across multiple tumor types approved based on combining five individual single-arm open label clinical trials.
FDA encouraged Merck to proceed based on breakthrough therapy designation. Anktiva has Breakthrough Therapy Designation (BTD). Priority review was denied in 2022 when BLA was filed despite BTD. Now Anktiva has RMAT status and Expanded Access Authorization across multiple tumor types for the same indication of patients who failed prior standard of care for which Merck received MSI-high approval across all tumor types.”
Other articles featuring Pat Soon-Shiong on OncoDaily.