Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non–small-cell lung cancer (NSCLC) Data on the efficacy and safety of adjuvant
Update 2025: Management of Non‑Small-Cell Lung Cancer - PMC Abstract Lung cancer remains the leading cause of cancer-related mortality worldwide Since 2024, the non–small-cell lung cancer (NSCLC) landscape has undergone a transformative shift, driven by 11 FDA approvals Recent advances in molecular profiling, targeted therapies, and immunotherapies have revolutionized NSCLC management, ushering in an era of personalized treatment with improved
FDA Approves Alectinib for ALK-Positive Lung Cancer Alectinib targets cancer cells that have specific changes, called rearrangements, in the ALK gene The drug has been shown to increase how long people with ALK-positive metastatic NSCLC live and has become a mainstay for treatment of people with this form of lung cancer
New Drug Application Submitted for Neladalkib in Advanced . . . A new drug application (NDA) to the FDA for neladalkib (NVL-655), an investigational, brain-penetrant, anaplastic lymphoma kinase (ALK)-selective tyrosine kinase inhibitor (TKI), has been submitted to the FDA The application seeks approval for the treatment of patients with advanced ALK-positive non–small cell lung cancer (NSCLC) who have previously received treatment with at least 1 ALK
Nuvalent Announces Submission of New Drug Application to FDA . . . Neladalkib has received breakthrough therapy designation from the U S Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC
FDA Submission Filed for Neladalkib in ALK+ Lung Cancer Nuvalent, Inc announced that it has submitted a new drug application (NDA) to the U S Food and Drug Administration (FDA) for neladalkib, an investigational treatment for patients with advanced ALK-positive non-small cell lung cancer who have previously received tyrosine kinase inhibitors, aiming to expand treatment options for this patient population Main data that support the findings The
NDA Is Submitted to FDA for Neladalkib in TKI-Pretreated . . . In May 2024, the FDA granted breakthrough therapy designation to neladalkib for the treatment of patients with locally advanced or metastatic ALK -positive NSCLC who have previously received 2 or
Developers Submit NDA for Neladalkib in Pretreated ALK+ NSCLC Additionally, the agent previously earned orphan drug designation as a treatment for patients with ALK -positive NSCLC Supporting data for the NDA came from the phase 1 2 ALKOVE-1 trial (NCT05384626) assessing neladalkib among those with ALK -positive NSCLC and other solid tumors