Keeping Track: Accelerated Approval Wins (Padcev+Keytruda) And Losses (Imbruvica To Shed MCL, MZL Claims)
The latest drug development news and highlights from the Pink Sheet's US FDA Perfomance Tracker.
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AbbVie/J&J Withdrawal Of Imbruvica Indications Clears Space For Competitors
The BTK inhibitor’s exit from MCL and MZL after lackluster Phase III confirmatory trial results gives AstraZeneca’s Calquence and BeiGene’s Brukinsa a potential shot at claiming the space.
Merck’s Keytruda And Seagen’s Padcev Become First PD-1/ADC Combo To Win US Approval
The blockbuster PD-1 inhibitor and antibody-drug conjugate will be used to treat a subset of first-line urothelial carcinoma patients considerably widening Padcev’s market, but rates of peripheral neuropathy with the combination have left some analysts concerned.
Two Years In US Accelerated Approval Withdrawals
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.