Novartis blood cancer drug given EU nod
pharmafile | March 17, 2015 | News story | Sales and Marketing | Cancer, EU, Jakavi, Novartis, oncology, polycythemia vera, ruxolitinib
Novartis’ blood cancer drug Jakavi has been given the green light in Europe to treat adult patients with polycythemia vera (PV), a disease which causes overproduction of blood cells.
Jakavi (ruxolitinib) is already approved in more than 80 countries to treat myelofibrosis – a serious bone marrow disorder.
“The approval of Jakavi in PV underscores what’s possible in today’s era of precision oncology research,” says Bruno Strigini, who is the president of Novartis Oncology.
“Jakavi specifically targets the JAK-STAT pathway, which regulates blood cell production and is known to play a key role in the underlying mechanism of this disease, bringing patients and doctors a new way to treat PV.”
The nod is based on data from Phase III clinical trials which demonstrated that a greater proportion of patients achieved the primary endpoint. The studies found a 50% or more improvement in PV-related symptoms in just under half of Jakavi-treated patients – compared to 5% of patients treated with current therapy.
Jakavi is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases – protein essential for signalling for certain type I and type II cytokines – and is the first-ever targeted therapy for PV in the EU.
PV is a disease where too many red blood cells are made in the bone marrow. These extra blood cells often assemble in the spleen causing it to swell, and can increase the risk of stroke or heart attack. Around two per 100,000 people are diagnosed with the condition each year with the average age of 60-years-old.
Novartis will be best pleased with this news whose recently-reported fourth quarter sales of $14.6 billion, a slight decrease of 2% from the same period last year. Trade of its Jakavi increased by 91%, but did have lower overall sales than other growth products at $84 million.
“The European Commission’s approval of Jakavi is encouraging news for patients,” comments Dr Claire Harrison, who is the study investigator and consultant haematologist at Guy’s and St. Thomas’ NHS Foundation Trust in London.
She concludes: “Jakavi will fill an unmet need as the first treatment shown to significantly improve haematocrit, as well as symptom control and reduce spleen size in patients with PV.”
Tom Robinson
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