- Swiss pharma Roche said Wednesday the Food and Drug Administration approved its cancer medicine Alecensa as a first-line treatment for patients with ALK+ non-small cell lung cancer (NSCLC), setting the drugmaker up to challenge Pfizer's Xalkori for a leading position in that market.
- Regulatory OK for the broadened indication was based on a head-to-head Phase 3 study that showed Alecensa cut the risk of disease worsening or death by 47% versus Xalkori.
- The FDA also converted Alecensa's accelerated approval, secured in December 2015, to a full approval in the second-line setting for patients who had progressed following treatment with Xalkori.
Approval now in hand — along with a recommendation from the National Comprehensive Cancer Network guidelines — and Alecensa (alectinib) looks set to become the standard of care in first-line ALK+ NSCLC.
Pfizer's Xalkori (crizotinib), first approved in 2011, has been regarded as standard treatment in this patient population for years. In Roche's ALEX study, however, Alecensa more than doubled the median progression-free survival seen from those treated with Xalkori. Notably, treatment with Roche's drug also reduced the risk of brain metastases by 84%.
While the ALK+ subgroup makes up only 5% of the larger NSCLC market, Alecensa's approval should help accelerate uptake of the drug. Last quarter, Roche recorded 96 million Swiss francs (roughly $96 million) in Alecensa sales — nearly double that of a year ago. Together with Ocrevus (ocrelizumab) in multiple sclerosis and the checkpoint inhibitor Tecentriq (atezolizumab), Alecensa has been an important source of new revenue for the pharma.
But aside from Xalkori, Roche will have some competition in the first-line ALK+ market.
Novartis AG's Zykadia (ceritinib) won first-line approval in May following positive Phase 3 results, and Takeda's Alunbrig (brigatinib) is currently OK'd in the second-line setting. The Japanese pharma hopes to break into earlier lines of treatment with a head-to-head study pitting Alunbrig versus Xalkori expected to complete in 2019.
Even Pfizer, not content with just Xalkori, is pushing forward with a follow-up drug called lorlatinib, currently in Phase 3. Mid-stage data looked good enough, however, for the big pharma to push for approval on that basis alone.
Elsewhere, Roche got another boost this week, securing an expanded approval for Zelboraf (vemurafenib) for a non-cancer indication — Erdheim-Chester disease with BRAF V600 mutation. A rare and potentially fatal blood disorder, Edheim-Chester disease causes white blood cells known as histiocytes to invade tissues through the body.
Roche used a basket trial for people with BRAF V600 mutation-positive cancers and other diseases in order to collect data to support approval more quickly.