Novartis faces a wait to find out if it can market a new cancer drug in the US after regulators requested more time to assess the drug.
The FDA has extended the review period by up to three months to examine panobinostat (LBH589) as a treatment for the blood cancer multiple myeloma.
The specific indication under review covers the drug’s use in combination with Velcade (bortezomib), marketed by Millennium Pharmaceuticals and Takeda, and the steroid dexamethasone.
Novartis did not give a reason for the FDA’s extension although there are concerns about the toxicity of panobinostat.
Earlier this month the FDA’s Oncologic Drugs Advisory Committee, which provides guidance to the FDA on new cancer drugs, voted 5-2 in favour of not recommending panobinostat in multiple myeloma after doubts were raised about the drug’s safety.
Data from a phase III trial showed that 7% of patients in the panobinostat arm died from non-cancer complications compared to just 3.5% in non-panobinostat group. Reported symptoms included myelosuppression, haemorrhage, infection, gastrointestinal toxicity and cardiac toxicity.
Due to the urgent need for new effective treatments in multiple myeloma – a cancer of plasma cells in bone marrow with a high relapse rate – panobinostat received priority review status when the FDA accepted the treatment’s New Drug Applications (NDA) earlier this year.
The designation aims to reduce the standard 12-month review period to eight months, although the extension now means the total review period could be 11 months.
Alessandro Riva, global head of oncology development and medical affairs for Novartis’s oncology business, said: “We are committed to working with the FDA as they continue to review the LBH589 NDA.
“Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options.