Takeda is getting a big bonus from the FDA today for its $5.2 billion buyout of Ariad. The pharma company acquired the late-stage cancer drug brigatinib in the acquisition back in January, and now the FDA has approved it for ALK-positive cases of non-small cell lung cancer.
Takeda can now set out to realize its projections of $1 billion-plus in annual sales for brigatinib — which will be marketed as Alunbrig — which are significantly more aggressive than most analysts, who have been predicting $500 million to $800 million in sales.
As is common these days, the FDA arranged a quick OK based on the latest study of two doses of the drug, also tagged as a breakthrough therapy, without a comparison arm. It is approved for patients who have failed on Pfizer’s Xalkori.
They key to its longterm success, though, likely lies in an ongoing Phase III study of the drug in first-line patients, dubbed ALTA 1L, in a head-to-head against Xalkori. That study launched a year ago.
In early December Ariad reported that at a follow-up of 11-months, the drug demonstrated a progression-free survival rate of 15.6 months with a 55% confirmed objective response rate for non-small cell lung cancer patients taking the 180 mg dose brigatinib.
The success today marks a big plus for Takeda CEO Christophe Weber, who raised eyebrows for paying a significant premium for Ariad, which also netted the marketed drug Iclusig. Weber and R&D chief Andy Plump have been ripping up the old R&D structure over the past year. And they cut 180 of the 300 Ariad staffers in the last two months — though some may have wound up with jobs at PRA.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,200+ biopharma pros who read Endpoints News by email every day.Free Subscription