This positive scientific opinion was issued to AstraZeneca UK Limited for osimertinib (AZD9291) 40 and 80 mg film-coated tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC) who have progressed on or after EGFR TKI therapy.
The scientific opinion includes:
- a public assessment report
- a treatment protocol:
- for healthcare professionals
- for patients
- on the pharmacovigilance system
Posted on the UK MHRA website on 7 December 2015