Neladalkib (NVL-655)
TKI-pretreated advanced ALK-positive non-small cell lung cancer · Patients with advanced ALK-positive NSCLC previously treated with an ALK tyrosine kinase inhibitor
NUVL · Nuvalent
Regulatory designations
Full timeline
4 milestonesFDA decision expected
FDA assigned a November 27, 2026 PDUFA target action date to the neladalkib NDA.
Nuvalent — NDA acceptance and PDUFA date↗FDA accepted the NDA with Priority Review
FDA accepted the application based on the registration-directed ALKOVE-1 Phase 1/2 trial in TKI-pretreated advanced ALK-positive NSCLC.
Nuvalent — NDA acceptance and Priority Review↗Positive pivotal ALKOVE-1 data were reported
Among 253 TKI-pretreated patients, the blinded independent central review objective response rate was 31%, with intracranial activity and durable responses reported.
Nuvalent — Positive pivotal ALKOVE-1 data↗Phase 1/2 ALKOVE-1 study started
ALKOVE-1 began evaluating neladalkib in patients with advanced ALK-positive non-small-cell lung cancer and other ALK-driven solid tumors, including the pivotal TKI-pretreated cohort.
ClinicalTrials.gov — ALKOVE-1 study record (NCT05384626)↗Related News
No related news available.