Ariad has filed for approval in the US for brigatinib - its second drug - after positive results in lung cancer were reported at the ASCO conference.
The 'rolling' submission for ALK inhibitor brigatinib is seeking approval for the drug in patients with ALK-positive non-small cell lung cancer (NSCLC) who are resistant to treatment with Pfizer's Xalkori (crizotinib).
The filing comes a little earlier than expected and has been possible because the FDA granted brigatinib breakthrough status in this indication, according to Ariad's chief executive Paris Panayitopolous. It puts brigatinib in contention for a possible launch early in 2017.
It is based on the results of the ALTA phase II trial, first unveiled at the ASCO meeting earlier this month, which showed that Ariad's drug achieved an overall response rate of 46% to 54%, depending on the dosage used. Median progression-free survival was around a year - roughly in line with other second-line ALK inhibitors.
Xalkori currently leads the ALK inhibitor category at present with sales of $488m last year and is one of Pfizer's fastest-growing drugs, with sales up 20% in 2015. It is the only drug in the class with a first-line claim on the label, having shown superiority to chemotherapy in pivotal trials.
However, despite clear benefits Xalkori's effects tend to be short-lived, with patients typically relapsing within the first year of treatment. After Xalkori loses activity, second-line options currently are Novartis' Zykadia (ceritinib) and Roche's recently-approved Alecensa (alectinib).
There is as yet little to indicate whether any of the three second-line ALK inhibitors have advantages over the others, or indeed whether there will be a benefit in giving them sequentially in a bid to extend the benefits of ALK-targeting therapy.
Lung cancer is the leading cause of cancer death in the US, with an estimated 221,200 new diagnoses and 158,000 deaths this year, according to the National Cancer Institute. NSCLC accounts for around 90% of all lung cancers, and ALK gene mutations are present in about 5% of NSCLC cases.
The filing of brigatinib is a big boost for Ariad, which needs new revenue streams to sit alongside its only marketed drug, Iclusig (ponatinib) for chronic myeloid leukaemia (CML).
Despite safety concerns which emerged in 2013 Iclusig has grown steadily to reach $112m in sales last year, and Ariad recently took the decision to sell rights to the drug outside its home US market in order to help kick-start overseas sales.
On Friday, the company announced it had licensed Latin American distribution rights to Pint Pharma International and Middle East/North Africa rights Biologix FZCo. Earlier this month it sold its EU operations as well as Iclusig rights to Incyte Corp.