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Latest From Oncopeptides AB
FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?
US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.
Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.
Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.
- Large Molecule