US regulators have issued a stamp of approval for Novartis’ first-in-class multiple myeloma drug Farydak (panobinostat), giving patients access to the first HDAC inhibitor to treat the blood cancer.
The US Food and Drug Administration has cleared the drug - which is administered alongside Johnson & Johnson/Takeda’s chemotherapy Velcade (bortezomib) and dexamethasone - for use in patients who have received at least two prior standard therapies.
The news will be particularly welcome given that, back in November, the FDA’s Oncologic Drugs Advisory Committee advised against approving the drug. But Novartis subsequently submitted additional information supporting Farydak’s third-line use, paving the way for its clearance.
Farydak has a novel mechanism of action different from other MM treatments on the market and, crucially is backed by clinical data showing that it can boost progression-free survival; patients receiving the Farydak regimen saw a delay in their disease progression for about 10.6 months versus 5.8 months in those given with Velcade and dexamethasone alone.
On the safety side, the drug does carry a boxed warning alerting patients and doctors that severe diarrohea and severe and fatal cardiac events, arrhythmias and electrocardiogram changes have been observed. Because of this, a Risk Evaluation and Mitigation Strategy has also been approved, consisting of a communication plan to inform health care professionals of these risks and how to minimise them.