Understanding the FDA Approval Process for ALK-Positive Drugs: When Will NVL-655 Be Available?

For those living with ALK-positive lung cancer, the search for new treatments feels like a race against time. When current therapies lose effectiveness, patients and their loved ones are left waiting for the next breakthrough. NVL-655, an experimental ALK inhibitor, is one of the most anticipated new treatments, designed specifically to overcome resistance mutations that develop after other ALK-targeted therapies.

Clinical TrialsKirk SmithMarch 29, 2025Clinical Trials, FDA, NVL-655

Phase II Clinical Trial NCT05384626 by Nuvalent, Inc. A Study of NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Who is this trial for: NVL-655 is a 4th generation, brain-penetrant, ALK TKI inhibitor created to overcome several limitations observed with currently available therapies. NVL-655 is designed to have activity in tumors that have developed resistance to first, second, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R/L1196M (“GRLM”), G1202R/G1269A (“GRGA”), or G1202R/L1198F (“GRLF”). In other words, it is for patients for whom other ALK TKIs have failed under certain conditions.

Clinical TrialsKirk SmithNovember 5, 2024Clinical Trials, Nuvalent, NVL-655, ALKOVE-1

ALKOVE-1 Study Results Summary: NVL-655’s Promising Role in Treating Advanced ALK+ Lung Cancer

The clinical results from the Phase 1 portion of the ALKOVE-1 study is bringing new hope to patients with ALK-positive lung cancer, especially those who have exhausted other treatment options. NVL-655, a fourth-generation ALK inhibitor, has shown unique effectiveness in overcoming resistance to previous treatments, including those with brain metastases and specific resistance mutations