neladalkib

Neladalkib is a novel, orally bioavailable, brain-penetrant small molecule inhibitor that selectively targets anaplastic lymphoma kinase (ALK). It was designed to overcome resistance mutations—including G1202R and compound ALK mutations—that limit the effectiveness of first-, second-, and third-generation ALK inhibitors in non-small cell lung cancer (NSCLC). Neladalkib demonstrates activity against tumors with single or compound treatment-emergent ALK mutations and is engineered for central nervous system (CNS) penetrance to address brain metastases. Importantly, it avoids inhibition of the tropomyosin receptor kinase (TRK) family to minimize TRK-related CNS adverse events. Neladalkib has received breakthrough therapy designation and orphan drug designation for locally advanced or metastatic ALK-positive NSCLC after prior treatment with two or more ALK tyrosine kinase inhibitors. The drug is being developed by Nuvalent for use in NSCLC as well as other solid tumors harboring ALK alterations.

Other names

neladalkib [INN]neladalkib [USAN]