FDA Drug Approvals: Oncology and Hematology — Year in Review 2018

Mary L Windle, PharmD


January 15, 2019

New Drugs for Non-Small Cell Lung Cancer

Vizimpro (dacomitinib)

Dacomitinib is indicated for first-line treatment of patients with metastatic non–small lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Dacomitinib is an irreversible kinase inhibitor of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR-activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation).

Approval of dacomitinib was based on the ARCHER 1050 trial (n=452). Compared with gefitinib, results showed a statistically significant improvement in progression-free survival (PFS) with dacomitinib; median PFS was 14.7 months with dacomitinib compared with 9.2 months with gefitinib (hazard ratio, 0.59; P<.0001). (Lancet Oncol. 2017 Nov;18(11):1454-1466) Overall survival analysis showed slight improvement with dacomitinib at 34.1 months compared with gefitinib at 26.8 months. (J Clin Oncol. 2018 Aug 1;36(22):2244-2250)

Lorbrena (lorlatinib)

Lorlatinib is an anaplastic lymphoma kinase (ALK) inhibitor. It is indicated for ALK-positive metastatic non–small cell lung cancer (NSCLC) in patients whose disease has progressed on crizotinib and at least one other ALK inhibitor, or alectinib or ceritinib as first ALK inhibitor therapy.

Accelerated approval of lorlatinib was supported by a single, open-label, phase 2 trial (n=215) in patients with ALK-positive metastatic NSCLC previously treated with an ALK inhibitor. The study demonstrated an overall response rate of 48% (4% complete response, 44% partial response), with a median duration of response of 12.5 months. Additionally, in a subgroup of patients with CNS metastases (n=89), the intracranial response rate was 60% (21% complete response, 38% partial response), with a median duration of response of 19.5 months. (Lancet Oncol. 2018 Dec;19(12):1654-1667)


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