November 10, 2021
Emma Shtivelman, PhD
Chemotherapy was once the only treatment available for metastatic or advanced non-small lung cancer (NSCLC). But the situation has changed dramatically in recent years. NSCLC may harbor mutations that drive cancer development, and many of these mutations can be targeted with precision drugs that inhibit specific mutant proteins. Targeted drugs not only often prolong survival of patients compared to chemotherapy, but they also improve… Read more »
December 12, 2018
FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC BookmarkEmma Shtivelman, PhD
“On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
“Approval was based on a subgroup of 215 patients with ALK-positive metastatic NSCLC, previously treated with one or more ALK kinase inhibitors, enrolled in a non‑randomized, dose-ranging and activity-estimating, multi‑cohort, multicenter study (Study B7461001; NCT01970865). The major efficacy measures were overall response rate (ORR) and intracranial ORR, according to RECIST 1.1, as assessed by an independent central review committee.”
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