FDA in Novartis cancer drug U-turn
pharmafile | February 24, 2015 | News story | Research and Development, Sales and Marketing |Â Â Cancer, FDA, Farydak, Novartis, Revlimid, Velcade, myelomaÂ
The FDA has overturned an earlier advisory committee recommendation and decided to approve Novartis’ blood cancer drug Farydak.
In November an advisory committee had advised the FDA to reject Novartis new drug application for Farydak (panobinostat), the first histone deacetylase (HDAC) inhibitor available to patients with multiple myeloma.
It has been approved in combination with Velcade (bortezomib) and dexamethasone for patients with multiple myeloma who have received at least two prior regimens, including Janssen’s Velcade and an immunomodulatory agent (that prompt a patient’s immune system to destroy myeloma cells, such as Celgene’s Revlimid (lenalidomide).
The advisory committee had considered results from the PANAROMA study, published in The Lancet Oncology in September 2014, which had found that people with hard to treat multiple myleome who took a combination of Farydak, Velcade and dexamethasone – the current standard of care – had a clinically meaningful four-month improvement in progression-free survival compared to people who had standard care and a placebo.
After initially recommending the treatment should be rejected, the FDA has backtracked and granted an accelerated approval. As such, if Novartis is to gain further approvals for this indication the Swiss company will have to provide further confirmatory trials to demonstrate that Farydak has clinical benefit.
It is also subject to a Risk Evaluation and Mitigation Strategy (REMS); a communication plan to inform doctors of the drug’s risks – which include diarrhoea and heart problems – and how to minimise them.
Bruno Strigini, president of Novartis oncology, says: “Novartis is committed to developing innovative first-in-class therapies for patients who need treatment options. Farydak represents a new drug class in multiple myeloma, providing these patients with an important treatment approach for this difficult-to-treat cancer.”
Dr Paul Richardson, from the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute who took part in the study, says: “Farydak represents an exciting agent with a new mechanism of action that is part of a promising class of drugs in this setting. Importantly, Farydak has been shown to improve progression-free survival in relapsed multiple myeloma patients who have received at least two prior regimens, which is an area of particular unmet medical need.”
Multiple myeloma is a cancer of white blood cells that predominantly affects the bone marrow, impacting approximately one to five in every 100,000 people worldwide each year, and is increasing in prevalence.
Lilian Anekwe
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