EU health officials have approved Novartis’ first-in-class multiple myeloma drug Farydak (panobinostat), giving patients access to the first HDAC inhibitor to treat the blood cancer.
The European Commission 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, including bortezomib and an immunomodulatory agent.
Farydak is the first cancer medicine to target enzymes known as histone deacetylases, offering a novel mechanism of action different from other MM treatments on the market. Clinical data show that it can boost progression-free survival; patients receiving the Farydak regimen saw a delay in their disease progression of about 7.8 months more than those given Velcade/dexamethasone alone.
But the drug is linked with some serious side effects. Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation and sinus tachycardia) were reported in 17.6% of Farydak-treated patients versus 9.8% of placebo-treated patients in the Phase III trial. And discontinuation due to adverse events, regardless of causality, was observed in 36.2% of patients, the most common being diarrhoea (4.5%), asthenia and fatigue (2.9% each) and pneumonia (1.3%).
The drug won clearance for the US market in February, where it carries a boxed warning alerting patients and doctors that severe diarrhoea and severe and fatal cardiac events, arrhythmias and electrocardiogram changes have been observed.