FDA approves ensartinib for ALK-positive locally advanced or metastatic NSCLC
“On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. The main efficacy outcome measure was progression-free survival (PFS) as evaluated by blinded independent central review. The key secondary efficacy outcome measure was overall survival (OS). Ensartinib demonstrated a statistically significant PFS improvement compared to crizotinib with a hazard ratio (HR) of 0.56 (95% CI: 0.40, 0.79; p-value 0.0007). The median PFS was 25.8 months (95% CI: 21.8, not estimable) in the ensartinib arm and 12.7 months (95% CI: 9.2, 16.6) in the crizotinib arm. There was no statistically significant difference in OS (HR 0.88 [95% CI: 0.63, 1.23], p-value 0.4570).”
Share:
More News
“Receiving orphan drug designation for amezalpat to treat HCC underscores the critical need for new treatment options for patients suffering from this historically hard to treat disease,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. “Tempest is dedicated to developing groundbreaking cancer treatments that
Dr. Samuel Zhang, Chief Business Officer of Innovent, stated: “We are delighted to once again enter a strategic collaboration with Roche, a global leader in oncology, to advance our potentially best-in-class DLL3 ADC candidate. By combining Roche’s scientific expertise and global development capabilities with our innovative approach, we are taking
“CARsgen Therapeutics, a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the initiation of an investigator-initiated trial (IIT) in China for KJ-C2219, an allogeneic CAR T-cell therapy, targeting CD19/CD20. The trial will evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin
“The FDA filing acceptance and Priority Review for the combination of avutometinib and defactinib underscores the critical unmet need among patients diagnosed with this rare and insidious disease. We are excited by today’s news and to potentially bring the first ever FDA-approved treatment specifically for recurrent KRAS mutant LGSOC to
