BMS gets speedy FDA review for Augtyro in tumour-agnostic indication

2024-02-15

优先审批上市批准并购临床结果

Bristol Myers Squibb announced that the FDA granted priority review to its application seeking approval of Augtyro (repotrectinib) for the treatment of patients aged 12 years and above with NTRK-positive solid tumours NTRK-positive solid tumours that are locally advanced or metastatic, or unsuitable for surgical resection. The agency is expected to decide on the filing by June 15.

Joseph Fiore, global programme lead for the ROS1/TRK tyrosine kinase inhibitor (TKI), said the unmet need in patients with NTRK-positive tumours warrants new treatment options that “improve durability of response and address resistance to existing TKIs.” Earlier this year, the EMA validated the drug’s marketing authorisation application for the same indication.

The applications are supported by positive findings from the Phase I/II TRIDENT-1 and CARE studies. In the TRIDENT-1 trial, Augtyro demonstrated significant overall response rates in patients with advanced NTRK-positive tumours, with durable responses even in those with common resistance mutations and intracranial responses, alongside a favourable safety profile. The CARE study further validated Augtyro in children and young adults with tumours harbouring ALK, ROS1 or NTRK1-3 mutations.

Augtyro made its way into Bristol Myers Squibb’s oncology portfolio through the $4.1-billion acquisition of Turning Point Therapeutics in 2022. The drug secured its first FDA approval for the treatment of ROS1-positive non-small-cell lung cancer ROS1-positive non-small-cell lung cancer in November last year.

Bristol Myers Squibb is not the only one keenly eyeing the tumour-agnostic space. Last month, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) also bagged an FDA priority review for the treatment of unresectable or metastatic HER2-positive solid tumours.

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