Dacomitinib Granted Priority Review for NSCLC With EGFR-Activating Mutations

The PDUFA goal date for a decision by the FDA is in September 2018
The PDUFA goal date for a decision by the FDA is in September 2018

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted priority review to dacomitinib (Pfizer), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. 

Dacomitinib is a pan-human EGFR tyrosine kinase inhibitor (TKI). The NDA is based on results from the Phase 3 ARCHER 1050 head-to-head trial in which patients were administered dacomitinib (n=227) or gefitinib (n=225) as first-line treatments. Results showed that those who received dacomitinib had median progression-free survival (PFS) of 14.7 months vs. 9.2 months in the gefitinib group, representing a risk reduction of 41% for disease progression or death (HR=0.59 [95% CI: 0.47–0.74], P<0.0001). 

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The FDA has set a Prescription Drug User Fee Act goal date of September 2018 for a decision on the NDA. "In the pivotal clinical trial that supports these applications, dacomitinib showed clinically meaningful improvement in progression-free survival over gefitinib, one of the first EGFR-targeted therapies to demonstrate activity in this disease," said Mace Rothenberg, MD and CDO of Oncology at Pfizer. 

The most common adverse events (AEs) in the ARCHER 1050 trial were diarrhea (87%), nail changes (62%), rash/dermatitis acneiform (49%), and mouth sores (44%). There was 1 case of Grade 5 diarrhea and 1 case of Grade 5 liver disease. The discontinuation rate due to treatment-related AEs for dacomitinib was 10% compared to 7% for gefitinib.

For more information visit Pfizer.com.