FDA News

FDA grants priority review to dacomitinib for EGFR-positive non-small cell lung cancer

The FDA granted priority review to dacomitinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations, according to the agent’s manufacturer.

Dacomitinib (PF-00299804, Pfizer) is a once-daily oral pan-human EGFR tyrosine kinase inhibitor.

The FDA based this priority review designation on the results from the phase 3 ARCHER 1050 trial of dacomitinib compared with gefitinib (Iressa, AstraZeneca).

Median PFS reached 14.7 months among patients randomly assigned to dacomitinib (n = 227) compared with 9.2 months among patients assigned gefitinib (n = 225), resulting in a 41% reduction in risk for disease progression or death (HR = 0.59; 95% CI, 0.47-0.74).

As HemOnc Today previously reported, results from this study were presented at the ASCO Annual Meeting last year.

“While significant progress has been made in the treatment of patients with non-small cell lung cancers harboring EGFR-activating mutations, it remains a challenging disease and new treatment options are needed,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a press release. “In the pivotal clinical trial that supports these applications, dacomitinib showed clinically meaningful improvement in PFS over gefitinib, one of the first EGFR-targeted therapies to demonstrate activity in this disease.”

The adverse events observed with dacomitinib appeared consistent with findings from previous trials. The most common adverse events included diarrhea (87%), nail changes (62%), rash/dermatitis acneiform (49%) and mouth sores (44%). The most common grade 3 adverse events included rash (14%) and diarrhea (8%). For dacomitinib-treated patients, 2% had grade 4 adverse events. Additionally, there was one case of grade 5 diarrhea and one case of grade 5 liver disease.

Ten percent of patients randomly assigned to dacomitinib discontinued treatment due to adverse events compared with 7% of treated with gefitinib.

The FDA granted priority review to dacomitinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations, according to the agent’s manufacturer.

Dacomitinib (PF-00299804, Pfizer) is a once-daily oral pan-human EGFR tyrosine kinase inhibitor.

The FDA based this priority review designation on the results from the phase 3 ARCHER 1050 trial of dacomitinib compared with gefitinib (Iressa, AstraZeneca).

Median PFS reached 14.7 months among patients randomly assigned to dacomitinib (n = 227) compared with 9.2 months among patients assigned gefitinib (n = 225), resulting in a 41% reduction in risk for disease progression or death (HR = 0.59; 95% CI, 0.47-0.74).

As HemOnc Today previously reported, results from this study were presented at the ASCO Annual Meeting last year.

“While significant progress has been made in the treatment of patients with non-small cell lung cancers harboring EGFR-activating mutations, it remains a challenging disease and new treatment options are needed,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a press release. “In the pivotal clinical trial that supports these applications, dacomitinib showed clinically meaningful improvement in PFS over gefitinib, one of the first EGFR-targeted therapies to demonstrate activity in this disease.”

The adverse events observed with dacomitinib appeared consistent with findings from previous trials. The most common adverse events included diarrhea (87%), nail changes (62%), rash/dermatitis acneiform (49%) and mouth sores (44%). The most common grade 3 adverse events included rash (14%) and diarrhea (8%). For dacomitinib-treated patients, 2% had grade 4 adverse events. Additionally, there was one case of grade 5 diarrhea and one case of grade 5 liver disease.

Ten percent of patients randomly assigned to dacomitinib discontinued treatment due to adverse events compared with 7% of treated with gefitinib.