Bristol Myers Squibb’s 2022 buyout of Turning Point Therapeutics for $4.1 billion continues to score wins at the FDA.
On Thursday, the agency announced that a drug acquired as part of the deal, Augtyro, won accelerated approval in adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and who have progressed following treatment or don’t have any other available drug. The approval came two days ahead of its PDUFA date.
Bristol Myers studied the drug, an oral tyrosine kinase inhibitor (TKI), in a single-arm, open-label trial of 88 adult patients with the type of cancer. According to the FDA, the overall response rate was 58% in patients who hadn’t received a TKI drug before, and 50% in the TKI-pretreated group.
The most common side effects included dizziness, fatigue, cognitive impairment, muscular weakness and nausea.
Augtyro first won FDA approval in November 2023 to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, where it competes with Pfizer’s Xalkori and Roche’s Rozlytrek. Both approvals were based on the results from the same trial, known as TRIDENT-1.
Bristol Myers reported about $6 million in revenue from Augtyro in the first quarter.