Novartis has bagged EU approval for its lung cancer therapy Zykadia, just over a year after it got a green light from the US FDA.
Zykadia (ceritinib) becomes the first treatment option approved in Europe for patients with ALK-positive non-small cell lung cancer (NSCLC) whose disease has progressed despite prior therapy with Pfizer/Merck KGaA's Xalkori (crizotinib).
The drug is already approved in 10 countries around the world - including the US where it had breakthrough status from the FDA- and brought in $16m in the first quarter of 2015. Analysts have predicted sales could eventually reach around $300m, somewhat shy of Xalkori's expected $800m peak revenues.
Like Xalkori Zykadia acts as an ALK inhibitor, although it has a slightly different profile, and approval in the EU is based on the results of two open-label studies in ALK+ NSCLC which suggest the drug achieved an overall response rate (ORR) of more than 56%.
NSCLC is the most common form of lung cancer - accounting for up to 90% of all the 1.6m cases diagnosed each year, with mutations in the ALK gene accounting for between 2% and 7% of NSCLC cases. Despite the availability of targeted drugs like Xalkori patients generally see their disease progress and there is a pressing need for new rounds of therapy.
"Patients with resistant ALK+ NSCLC have had very few treatment options available that specifically target the genetic makeup of their disease," said Stefania Vallone of patient group Women Against Lung Cancer in Europe.
"The approval of Zykadia brings new hope to the lung cancer community as we continue to advocate for innovative therapies."
Novartis is also carrying out clinical trials of Zykedia as a first-line therapy for treatment-naïve ALK+ NSCLC patients, which would allow it to compete more directly with Xalkori. Pfizer's drug achieved sales of $111m in the first quarter of this year and is expected to gain traction with the co-promotion with Merck coming into force.
Meanwhile, other companies with ALK inhibitors in development include Roche/Chugai with alectinib (RG7853) - which was approved in Japan last year and is in late-stage trials elsewhere - and Ariad with brigatinib (AP26113) which is in phase I/II testing.