The FDA has said Novartis’ Zykadia can be used as a first-line treatment option for some patients with non-small cell lung cancer (NSCLC), setting up a head-to-head battle in the market with Pfizer’s rival drug Xalkori.
The regulator has cleared Zykadia (ceritinib) for use in treatment-naive patients with metastatic NSCLC whose tumours are ALK-positive, extending the indications of the drug beyond its former role as a second line option for patients who progressed on or are intolerant to Xalkori (crizotinib), which brought in sales of $561m last year.
EU approval for Zykadia looks likely in the coming weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on first-line use last week, allowing Novartis to try to compete with Pfizer’s drug on an equal footing.
The FDA approval is based on the phase III ASCEND-4 trial, in which patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for those who received first-line pemetrexed-platinum chemotherapy followed by pemetrexed alone as a maintenance therapy.
Bruno Strigini, chief executive of Novartis Oncology, said this “represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this important medication to a patient population where a need still exists”. Around 3-7% of all patients with NSCLC have an ALK gene rearrangement.
The approval is good news for Novartis, although its key competitor in the coming period will not be so much Xalkori as Roche’s ALK inhibitor Alecensa (alectinib), which bested Pfizer’s drug in the head-to-head ALEX trial reported earlier this year.
Alecensa is approved for first-line ALK-positive NSCLC in Japan, with Roche claiming almost two-thirds market share versus Xalkori, and ALEX will form the basis of marketing applications in Europe and the US. The FDA awarded Alecensa breakthrough status in first-line NSCLC last October.
Alecensa’s ascendency can be seen in recent sales figures. First-quarter sales of Alecensa more than doubled to almost $70m in the period, while Novartis no longer lists Zykadia among its top oncology products. Last year sales of Zykadia and Alecensa were $91m and $182m respectively.
Meanwhile additional competition in the ALK inhibitor market is looming following accelerated approval of Takeda’s Alunbrig (brigatinib) by the FDA a few weeks ago.