All being well, Novartis could get FDA approval for its ALK inhibitor Zykadia as a first-line treatment for lung cancer within the next six months.
The FDA has started a priority review of the new indication for Zykadia (ceritinib) based on data showing it can improve progression-free survival (PFS) in previously-untreated patients with ALK-positive advanced non-small cell lung cancer (NSCLC).
Patients taking Xalkori invariably relapse, often within 12 months of starting treatment with the drug, due to the development of resistance in tumour cells.
Zykadia was first approved in 2015 as a second-line option for ALK-positive NSCLC patients whose disease had progressed despite earlier treatment with Pfizer/Merck KGaA’s rival ALK inhibitor Xalkori (crizotinib) but if the latest filing is successful Novartis will be able to compete head-to-head for newly-diagnosed patients.
Approval will also give Novartis an opportunity to make headway against other competitors in the second-line setting, such as Roche’s fast-growing Alecensa (alectinib), which was also approved in the US in 2015 and just got a green light in Europe for post-Xalkori treatment, as well as Ariad’s recently filed brigatinib.
At the moment, Novartis’ brand is struggling a little. Zykadia brought in $91m in sales last year, with sales actually shrinking in the fourth quarter due to competition in the US market. For comparison, Alecensa sales were around $180m last year while Pfizer booked $927m from Xalkori.
It may be pertinent that Roche released data from a Japanese study last year, which pointed to a significant PFS improvement for Alecensa over Xalkori in the second-line setting, and Novartis will be hoping that approval for first-line use will help it start a comeback.
The FDA priority review is based on phase III ASCEND-4 study results showing 16.6 month PFS in previously untreated ALK-positive metastatic NSCLC patients on Zykadia, more than double the 8.1 months improvement seen in patients treated with chemotherapy.
The US regulator has also awarded Zykadia breakthrough therapy status based on phase III data in patients with metastases to the brain, which could also help position the drug competitively versus its rivals.