The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for Nuvalent’s brain-penetrant anaplastic lymphoma kinase (ALK)-selective tyrosine kinase inhibitor (TKI), NVL-655 for the treatment of non-small cell lung cancer (NSCLC).

NVL-655 is intended to treat patients with locally advanced or metastatic ALK-positive NSCLC and have previously been treated with two or more ALK TKIs.

This asset is designed to address the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events.

These issues are commonly associated with the hindering of the structurally related tropomyosin receptor kinase (TRK) family.

The FDA granted BTD based on the initial efficacy and safety data from the Phase I segment of the Phase I/II ALKOVE-1 clinical trial.

The Phase II portion of the ALKOVE-1 trial is currently enrolling participants, with Nuvalent planning to present updated data in the second half of this year.

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BTD status is given to expedite the development and review of drugs intended to treat serious conditions, where initial evidence suggests the drug may significantly improve upon existing therapies.

Under BTD, the US regulator offers intensive guidance and the possibility of a rolling review to quicken the drug’s assessment.

NVL-655 had previously been awarded orphan drug designation for the treatment of ALK-positive NSCLC.

Nuvalent chief development officer Darlene Noci said: “The announcement of FDA breakthrough therapy designation for NVL-655 marks another important milestone for our ALK programme and the second breakthrough designation granted to our pipeline of novel kinase inhibitors this year.

“Our team is committed to expeditiously advancing NVL-655 in recognition of the continued need for innovation for patients with ALK-positive NSCLC who have exhausted available therapies. We expect to provide an update from the ALKOVE-1 trial of NVL-655 at a medical meeting in the second half of this year.”