Gilotrif afatinib regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Giotrif afatinib from Boehringer Ingelheim to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in EGFR mutation-positive patients who are EGFR tyrosine kinase inhibitor (TKI)-naïve - its approved indication. The recommendation is contingent on Boehringer providing the dual inhibitor of EGFR and HER2 at an undisclosed discount under a patient access scheme. The committee did not issue draft guidance because the recommendation is in line with Giotrif's approved indication in the EU. Comments are due March 31. ...