^
Association details:
| Biomarker: | ALK positive |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | NVL-655 (ALK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655
Published date:
05/16/2024
Excerpt:
Nuvalent, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).
Source:
Title:
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1) A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
Excerpt:
...Prior anticancer treatment: a. Phase 1: Patients with ALK fusion-positive NSCLC must have previously received > or =1 ALK TKI, one of which must be a 2nd or 3rd generation TKI (ceritinib, alectinib, brigatinib, or lorlatinib). ...
Trial ID:
