US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs

 
• By Sue Sutter

Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.

Safety vests
FDA has issued safety alerts about Pepaxto and Copiktra, two of the three drugs ODAC will discuss at a September meeting. • Source: Shutterstock

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