Shots:
- The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC
- NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be presented in future
- Neladalkib is an ALK-selective inhibitor that received the FDA’s breakthrough therapy designation for locally advanced or metastatic ALK-positive NSCLC pts who were previously treated with ≥2 ALK-TKI & orphan drug designation for ALK-positive NSCLC
Ref: PRnewswire | Image: Nuvalent | Press Release
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