Giotrif afatinib regulatory update

Germany's Federal Joint Commission (G-BA) issued a final benefit assessment for Giotrif afatinib from Boehringer Ingelheim to treat non-small cell lung cancer (NSCLC). According to Boehringer, G-BA said Giotrif has considerable benefit in previously untreated patients with exon 19 deletion EGFR gene mutations and additional benefit in in patients with exon 21 (L858R) substitution EGFR gene mutations compared to cisplatin plus pemetrexed. G-BA said the dual inhibitor of EGFR and HER2 led to less benefit in patients with other EGFR gene mutations and no additional benefit for previously treated patients and treatment-naïve patients who are capable of all selfcare but unable to carry out any work activities. The assessment is in line with a February preliminary benefit assessment from Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) (see BioCentury, Feb. 24). ...