Three drugs put forward for EMA authorisation
pharmafile | March 2, 2015 | News story | Research and Development, Sales and Marketing | Amgen, EMA, FDA, Novartis, Otsuka, jinarc, ristempa, zykadia
Novartis’ lung cancer drug Zykadia has been recommended for EU approval in patients previously treated with Pfizer’s Xalkori – the only other approved ALK tyrosine kinase inhibitor.
If approved by the European Medicines Agency (EMA) Zykadia (ceritinib) will be able to treat adult patients with anaplastic lymphoma kinase (ALK+) advanced non-small cell lung cancer (NSCLC).
A nod will make it the first treatment option to address an unmet medical need for patients with ALK and NSCLC previously treated with Pfizer’s Xalkori (crizotinib).
The inhibitor was shown the green light in the US last year under an accelerated programme, which saw the drug hit the market four months quicker than originally expected.
“Patients with advanced ALK+ NSCLC have few options when their cancer does not respond to currently approved therapy,” says Alessandro Riva, who is the global head of Novartis Oncology Development and Medical Affairs. “This positive opinion for Zykadia brings us one step closer to providing the lung cancer community with new hope in the fight against this terrible disease.”
The recommendation was based on results from two studies which reported a median duration of response at 8.3 and 9.2 months, respectively. The most common adverse reactions included diarrhoea, nausea, vomiting, and tiredness.
This news comes alongside the EU approval recommendation for Otsuka’s Jinarc (tolvaptan) – the first therapy available in Europe for patients with autosomal dominant polycystic kidney disease (ADPKD).
Jinarc was first approved in Japan last year and in Canada earlier this month. ADPKD causes cyst growth in the kidneys resulting in complications that include chronic and acute pain, hypertension and kidney failure.
Around one or two in every 1,000 people are born with ADPKD, and there are currently around 60,000 people in the UK living with the condition. In Europe it is estimated that around 205,000 people are affected.
Also put forward to the EMA is an application for Amgen’s Ristempa (pegfilgrastim) for the treatment of neutropenia – an abnormally low level of neutrophils, a type of white blood cell.
A final decision regarding all three treatments is likely to be made over the next three months.
Tom Robinson
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