The European Medicines Agency (EMA) has validated the marketing authorisation application of Bristol Myers Squibb (BMS) for repotrectinib to treat solid tumours.

A next-generation tyrosine kinase inhibitor (TKI), repotrectinib treats ROS1 [receptor tyrosine kinase] TKI-naïve and pre-treated adults with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

It is also being analysed for use in TKI-naïve and pre-treated patients aged 12 years and above with NTRK [neurotrophic tyrosine receptor kinase]-positive locally advanced or metastatic solid tumours.

The EMA validation marks the conclusion of the application’s submission and the beginning of the centralised review process by the agency.

BMS filed its application for repotrectinib based on findings from the registrational Phase I/II TRIDENT-1 trial in adults with ROS1-positive NSCLC or NTRK-positive solid tumours, as well as the CARE study in paediatric subjects with NTRK-positive solid tumours.

Repotrectinib showed clinically meaningful response rates in patients with ROS1-positive NSCLC and NTRK-positive solid tumour, demonstrating durability of response and intracranial activity in both settings, including in subjects with common resistance mutations.

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By GlobalData

The treatment was described as well-characterised and generally manageable.

Repotrectinib was approved by the US Food and Drug Administration (FDA) in November 2023 as Augtyro for usage in adults with locally advanced or metastatic ROS1-positive NSCLC.

BMS repotrectinib global programme lead and executive director Joseph Fiore stated: “While there are existing TKIs for the treatment of ROS1-positive non-small cell lung cancer and NTRK-positive solid tumours, there is still an undeniable need for new options that may offer patients more durable responses, including those with metastatic disease to the brain, and may address the issue of treatment resistance for patients with these aggressive and rare tumours.

“The clinical trial results with repotrectinib highlight the potential for this next-generation therapy to become a best-in-class option for patients with tumours harbouring ROS1 fusions and a new option for those with NTRK-fusion positive tumours, two groups who each continue to face a high unmet medical need.”

In December 2023, the company entered a definitive agreement to acquire biopharmaceutical company Karuna Therapeutics for $14bn.