Adalvo has received marketing authorisation via the DCP for its generic Afatinib film-coated tablets in Europe. The approval covers all strengths: 20, 30, 40 and 50 mg.
Afatinib is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations and belongs to the established class of EGFR tyrosine kinase inhibitors.
To discuss licensing and partnership opportunities for Afatinib, or to explore Adalvo's full oncology portfolio, contact one of the team today.
Afatinib works by irreversibly blocking the ErbB family of proteins involved in tumour growth and progression in EGFR-mutated NSCLC. Unlike first-generation EGFR inhibitors, it binds covalently, resulting in prolonged inhibition of ErbB signalling.
NSCLC accounts for approximately 85% of all lung cancer cases globally. EGFR mutations occur in around 10–35% of NSCLC adenocarcinomas, with higher prevalence observed in Asian populations.
According to IQVIA, MAT sales for Afatinib reached $229M in Q4 2025.
With marketing authorisations now in place across EU markets, Adalvo can offer partners licensing opportunities to bring this approved generic to patients.
The successful development of Afatinib further strengthens Adalvo’s oncology portfolio and demonstrates its capabilities in developing and delivering complex solid oral oncology therapies.
To discuss partnership opportunities or to explore Adalvo's full oncology pipeline, contact us today.