Istodax’s Lymphoma Accelerated Approval Indication Falls Victim To Failed Confirmatory Trial
BMS’ histone deacetylase inhibitor is the first oncology drug outside the PD-1/L1 class to lose an indication under US FDA’s recent review of ‘dangling’ accelerated approvals. Claim for second-line peripheral T-cell lymphoma was withdrawn because first-line study failed to meet its progression-free survival endpoint.
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239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval
Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.
Keytruda's Urothelial Cancer Claim Goes From Accelerated To Full Approval, With More Limited Scope
US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.
Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal
Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.