FDA's cancer drug advisors will review 2 more dangling accelerated approvals for multiple myeloma, leukemia
In an attempt to get its house of accelerated approvals in order, the FDA is holding its second adcomm of 2021 to review cancer drugs that won accelerated approvals but failed to confirm clinical benefit in subsequent trials or have taken a long time to read those data out.
On Dec. 2, the FDA’s Oncologic Drugs Advisory Committee will review two accelerated approvals from Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, as a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years.
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