Dacomitinib, the drug approved by the FDA in April 2019 for treating lung cancer, produces severe frequent side effects along with worsening of patients' symptoms and their health-related quality of life. Additional benefit of Dacomitinib in comparison with the appropriate comparator therapy is not proven, according to the new benefit assessment.
The drug was as the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations produces severe frequent side effects.
Only data on one of two research questions
The drug manufacturer did not present study data on this second research question in its dossier, so that an added benefit of dacomitinib is not proven for this reason alone. For the first research question, there are data from the unblinded randomized controlled trial ARCHER 1050, in which patients - predominantly Asians - were treated with either dacomitinib or gefitinib.
Patients reported numerous disadvantages
With about 34 months, the median survival time in the dacomitinib arm of the study was just over seven months longer than in the gefitinib arm (just under 27 months). In addition, there were isolated advantages regarding certain side effects. However, this was offset by a large number of disadvantages: Numerous side effects, particularly including severe side effects, were more common under dacomitinib. Patient-reported symptoms worsened more frequently and also earlier. Deterioration of health-related quality of life was also more pronounced than under gefitinib.
"Particularly the deterioration in quality of life is remarkable; data are rarely as clear as they are here," says Thomas Kaiser, Head of IQWiG's Drug Assessment Department. "The patients found their global health status, their role functioning, their cognitive functioning and their social functioning to be more impaired than under gefitinib." Overall, the negative effects outweigh the positive effect on overall survival. An added benefit of dacomitinib in comparison with the appropriate comparator therapy is therefore not proven.
G-BA decides on the extent of added benefit
The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.
More English-language information will be available soon (Sections 2.1 to 2.5 of the dossier assessment as well as easily understandable information on informedhealth.org). If you would like to be informed when these documents are available, please send an e-mail to email@example.com.