15 June 2016 - No direct comparative studies / effects in historical comparisons too small for statements for additional benefits.

Osimertinib mesylate (Tagrisso) has been available since February 2016 to treat adult patients with locally advanced or metastatic non small cell lung cancer and a T790M mutation of the epidermal growth factor receptor. In an early benefit assessment, the IQWiG has investigated whether the drug this patient has an additional benefit over the appropriate comparator therapy.

The comparator was different depending on pre-treatment and the mutation status of the patient. An additional benefit was not seen for any of the comparisons, because the manufacturer did not submit appropriate and meaningful trial data. The effects in the historical comparisons are too small to derive statements about an additional benefit.

For more details, go to: https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/osimertinib-bei-lungenkrebs-zusatznutzen-nicht-belegt.7391.html?&et_cid=4&et_lid=8 [German]