Nuvalent has submitted an NDA to the FDA for neladalkib, a brain-penetrant ALK-selective TKI for pretreated advanced ...
Nuvalent seeks FDA approval of neladalkib for TKI-pretreated advanced ALK-positive NSCLC, leveraging ALKOVE-1 results demonstrating activity in extracranial disease and brain metastases. ALKOVE-1 ...
FDA fast track designation applies to ALK+ NSCLC progressing after ≥2 ALK TKIs, reflecting limited post-lorlatinib therapeutic options and enabling more frequent FDA interactions and potential rolling ...
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the ...
Investigators at Massachusetts General Hospital in Boston conducted an analysis of the fusion oncogene EML4-ALK and the more well-studied epidermal growth factor receptor (EGFR) mutation among a group ...
Risks of Organ Preservation in Rectal Cancer: Data From Two International Registries on Rectal Cancer Clonal and subclonal mutations (variant allele frequency ≥5%) in ALK confer inferior prognosis for ...
Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with ALK-Positive ...
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively In the ...
Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations supports ongoing Phase 2 investigation in earlier lines of treatment "Our development strategy has been anchored ...
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