Novartis announced Friday that its Farydak capsules have been approved by the European Union as a treatment for adults with refractory and/or relapsed multiple myeloma, to be used alongside dexamethasone and bortezomib.
Farydak's approval signifies the first time that a histone deacetylase (HDAC) inhibitor featuring epigenetic activity was made available in the European Union, offering a new option for treatment for those living with multiple myeloma whose condition have worsened after receiving standard therapy. According to Philippe Moreau from the Centre Hospitalier Universitaire de Nantes, France, Farydak offers a new mechanism of action, which may improve the effectiveness of response to standard-of-care treatment in patients.
Multiple myeloma is a type of cancer that forms in plasma cells, a type of white blood cell found in the bone marrow. As an HDAC inhibitor and the first of the drug class to exhibit efficacy in multiple myeloma, Farydak is hoped to restore cell function through its epigenetic activity.
The cancer drug's approval was based on safety and efficacy data gathered during a subgroup analysis involving 147 patients who received a minimum of two regimens prior to being administered Farydak, including an IMiD and bortezomib, in a Phase III placebo-controlled, double-blind, randomized, multicenter global registration trial.
The most common of non-hematological adverse reactions reported during the trial included vomiting, nausea, fatigue and diarrhea, while hematological toxicities that emerged during treatment included lymphopenia, neutropenia, anemia and thrombocytopenia. Cardiac events, like sinus tachycardia and atrial fibrillation, were observed in 17.6 percent of patients given Farydak and 9.8 percent of those on placebo. About 36.2 percent of patients also had to discontinue participating because of adverse events, diarrhea, fatigue and asthenia, and pneumonia.
"With the approval of Farydak in the European Union, we hope to address critically important treatment needs faced by the multiple myeloma community," said Bruno Strigini, Novartic Oncology president, citing treatment resistance and disease progression as crucial issues.
He also boasted that the milestone, Farydak's approval, was the result of over 13 years of focused research, which helped Novartis better understand how multiple myeloma develops.
In combination with dexamethasone and bortezomib, Farydak is also approved for use in Japan, Chile and the U.S. Exact indications, however, vary by country to country. In the U.S., the drug is approved for treating multiple myeloma in patients who have undergone at least two kinds of treatment beforehand, including an IMiD and bortezomib.
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