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FDA grants Roche’s alectinib priority review for lung cancer

Expedited review given for ALK-positive lung cancer treatment
Roche building

Roche's alectinib has been granted priority review for the treatment of specific types of lung cancer.

Alectinib, which was granted 'breakthrough' drug in 2013 by the FDA, will now be reviewed within six months.

The decision was based on two studies showing the drug shrank tumours in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) who have progressed, or are intolerant to, Pfizer's Xalkori (crizotinib).

Sandra Horning, CMO and head of global product development at Roche's Genentech, said: “There is a need for new treatment options in this patient population especially because the disease often spreads to the brain at progression.”

The submission for alectinib comes from data from two phase II studies, NP28761 and NP28673. The former showed that for those whose tumours shrank, the response rate continued for a median of 7.5 months and progression-free survival (PFS) rates were 6.3 months.

Additionally, in the NP28673 trial patients continued to respond to treatment for a median of 11.2 months with median PFS standing at 8.9 months.

Alectinib also showed a 69% response rate in the central nervous system for those whose condition had spread to the brain.

An ongoing phase III trial, called ALEX, is comparing alectinib to Xalkori as an initial first-line treatment for ALK-positive tumours which are determined by an immunohistochemistry (IHC) test developed by Roche diagnostics.

If approved, alectinib will be competing with Novartis' Zykadia (ceritinib) and potentially Ariad's brigatinib, which has shown promising results in phase II trials. 

According to analysts the global NSCLC market value is set to rise from $6.9bn in 2014 to nearly $11bn by 2021.

Much of the growth will be driven by the introduction of drugs such as Bristol-Myers Squibb's Opdivo (nivolumab) and Merck's Keytruda (pembrolizumab), which was also granted priority review in June this year.

Article by
Nikhil Patel

10th September 2015

From: Regulatory



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