Speedy approval for Onyx’ multiple myeloma drug
pharmafile | July 24, 2012 | News story | Research and Development, Sales and Marketing | FDA, Janssen, Kyprolis, Onyx, Takeda, Velcade
Onyx’ Kyprolis has gained an accelerated approval by the FDA to treat patients with late-stage multiple myeloma.
Kyprolis (carfilzomib), a proteasome inhibitor, is now approved in the US for the treatment of patients with multiple myeloma who have received at least two prior therapies, including Takeda’s Velcade (bortezomib) and an immunomodulatory agent.
The new licence states that patients should also have demonstrated disease progression on or within 60 days of completion of the last therapy.
The approval has been speeded up by the agency as multiple myeloma is a rare condition with few treatment options, and because it is indicated for patients who have an advanced form of the disease.
But the indication has been granted without any progression-free survival or overall survival data – the approval was instead based on a Phase IIb study that showed increased response rates for patients using the drug for nearly eight months.
The firm said however that it would conduct a further Phase III confirmatory clinical trial, which it hopes will prove that it can also increase survival rates.
Onyx has an agreement with the FDA on a Special Protocol Assessment for this trial, given that it has already been approved based on a mid-stage study.
Analysts expect the multiple myeloma market to reach $5.4 billion by 2016, with Kyprolis expected to take around $600 million of that.
Onyx said 10,000 to 15,000 Americans would be eligible for the treatment, which will be available to order from doctors by 1 August. The drug will cost $1,658 per vial, or about $9,550 for a typical cycle of six vials.
“Today’s approval is a significant milestone for Onyx and, most importantly, for patients with advanced myeloma who have few treatment options available to them,” said N. Anthony Coles, president and chief executive of Onyx Pharmaceuticals.
“We are committed to continuing the clinical development of Kyprolis across earlier stages of multiple myeloma treatment,” he added.
This will take in more in line with Takeda’s drug, which is licensed in the US to treat the condition as a first line therapy, meaning it can be used by more patients.
Velcade, which also has a licence to treat another rare form of blood cancer, made just under $700 million in sales last year, and Onyx will hope to take some of that market share if it can gain earlier licences in the future.
Ben Adams
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