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

21 Jul 2022

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

Issues of safety, tolerability and dose optimization will be at the heart of a two-day US Food and Drug Administration advisory committee meeting on three cancer drugs, two of which are facing potential withdrawal of approved indications due to adverse survival trends in postmarketing studies.

On 22 September, the Oncologic Drugs Advisory Committee will discuss Spectrum Pharmaceuticals Inc.'s new drug application for poziotinib in...