FDA Grants BTD to Nuvalent’s NVL-655 for NSCLC

May 21, 2024

FDA has granted Nuvalent breakthrough therapy designation (BTD) for NVL-655 in treating patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have previously been treated with two or more ALK tyrosine kinase inhibitors (TKIs).

This FDA decision was supported by early data from the phase 1 portion of the ongoing phase 1/2 ALKOVE-1 clinical trial for NVL-655, offering hope for patients with NSCLC.

Darlene Noci, CMO at Nuvalent, acknowledged the FDA for granting BTD to NVL-655, marking another important milestone for their ALK program and the second BTD granted to their pipeline of novel kinase inhibitors, highlighting the potential of research and development efforts.

She acknowledged the team’s commitment to expeditiously advancing NVL-655, recognizing the ongoing need for innovation for patients with ALK-positive NSCLC who have exhausted available therapies.

The upcoming update on NVL-655 from the ALKOVE-1 trial at a medical meeting later in the year underscored the commitment to advancing oncology treatment options for NSCLC.

Nuvalent is currently enrolling NSCLC patients in the phase 2 portion of the trial for NVL-655 and expects to share updated data at a medical meeting in 2024.

Source: Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655