- Novartis was expecting an FDA decision regarding the approval of its oncology drug panobinostat, which is intended to treat multiple myeloma, by this week, but the FDA has informed the company that it will not provide a decision for another three months.
- The expectation surrounding the FDA's review of panobinostat was that it would not be approved. Earlier this month, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 5 to 2 against recommending panobinostat for approval based on safety concerns about the reliability of panobinostat's efficacy data.
- If panobinostat is approved, the FDA will most likely attach restrictions to its approval, such as stricter patient eligibility for treatment with panobinostat.
After ODAC expressed its concerns abotu panobinostat's safety and the reliability of its eficacy data, several myeloma experts, as well as Novartis employees, tried to address these concerns. However, it was clear that there were many unanswered questions. So the fact that the FDA has put off a decision for another three months is encouraging. It may mean that the FDA will approve panobinostat. If that happens, it will most likely be qualified and more restrictive than Novartis would like. Still, an approval would bode well all around—assuming the safety issues is cleared up.