FDA OKs New First-Line Treatment for Non-Small Cell Lung Cancer

Dacomitinib tablets (Vizimpro, Pfizer) received FDA approval for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC), the agency announced in a news release.

The drug is indicated for patients with NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

The approval was based on data from the ARCHER 1050 clinical trial comparing the safety and efficacy of dacomitinib with gefitinib in 452 patients with unresectable, metastatic NSCLC. For the trial, patients were required to have no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy, an Eastern Cooperative Oncology Group performance status of 0 or 1, EGFR exon 19 deletion or exon 21 L858R substitution mutations.

Patients enrolled in the trial who received dacomitinib demonstrated a significant improvement in progression-free survival (PFS), although no improvement in overall response rate or overall survival were demonstrated. The median PFS was 14.7 and 9.2 months in the dacomitinib and gefitinib groups, respectively.

Additionally, among 227 patients with EGFR-mutated metastatic NSCLC who received the treatment, the most common adverse effects were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritis (21%). The most common serious adverse reactions reported were diarrhea and interstitial lung disease.

“EGFR-mutated advanced non-small cell lung cancer is a common illness, especially in the Asian population, and new treatment options will ultimately benefit patients,” Tony Mok, MD, primary investigator for the ARCHER 1050 study and chair of the department of clinical oncology at The Chinese University of Hong Kong, said in a statement. “The findings from ARCHER 1050 suggest that Vizimpro should be considered as a new first-line treatment options for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations.”

The recommended dose of dacomitinib is 45 mg taken once orally, once daily, with or without food, according to Pfizer. If dose reduction is necessary, then the first dose reduction should be to 30 mg once daily and second dose reduction should be to 15 mg once daily.

Dacomitinib was previously granted Priority Review for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR-activating mutations.

Reference

US FDA Approves Vizimpro (Dacomitinib) for the First-Line Treatment of Patients With EGFR-Mutated Metastatic Non-Small Cell Lung Cancer [news release]. Pfizer’s website. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_vizimpro_dacomitinib_for_the_first_line_treatment_of_patients_with_egfr_mutated_metastatic_non_small_cell_lung_cancer. Accessed September 28, 2018.