NEW YORK – The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday authorized osimertinib (AstraZeneca's Tagrisso) as an adjuvant, post-surgical treatment for EGFR-mutated, early-stage non-small cell lung cancer patients.
This is the first such authorization the MHRA has made through Project Orbis, a program spearheaded by the US Food and Drug Administration that allows drug sponsors to pursue expedited review of oncology products simultaneously in different countries. In January, the UK became a partner in the project, joining the US, Canada, Australia, Switzerland, Singapore, and Brazil.
Osimertinib is already available to advanced NSCLC patients within the National Health Service (NHS) England. Based on data from the Phase III ADAURA trial, AstraZeneca, NHS England, and the National Institute for Health and Care Excellence (NICE), which conducts cost-effectiveness analysis to determine whether the government should fund specific drugs, struck up an agreement to facilitate early access to osimertinib as an adjuvant therapy for NSCLC.
According to a statement from the MHRA, AstraZeneca is providing osimeritinib "on a budget-neutral basis to the NHS while NICE undertakes its appraisal." NICE is expected to publish a health economic analysis for osimertinib in this setting in September 2021 at the earliest, according to AstraZeneca.
The FDA approved this same indication last year based on data from ADAURA, in which median disease-free survival in patients with stage II to IIIA tumors was not reached in the osimertinib arm and 19.6 months in the placebo arm. In the overall population, including patients with stage Ib to III disease, median disease-free survival was again not reached in the osimertinib arm and 27.5 months in the placebo arm. The trial was unblinded early after an independent data monitoring committee determined that adjuvant osimertinib demonstrated "overwhelming efficacy" based on the disease-free survival endpoint.