NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Tuesday issued a final guidance recommending AstraZeneca's Tagrisso (osimertinib) as an adjuvant treatment for patients with EGFR-mutated non-small cell lung cancer.
NICE estimates that nearly 600 people with this type of cancer in England could benefit from Tagrisso. Patients have been able to access the EGFR tyrosine kinase inhibitor through the Cancer Drugs Fund (CDF) since January 2022, but the new draft guidance recommends that it become available for routine treatment within the National Health Service.
Initially, NICE recommended offering adjuvant Tagrisso through the CDF rather than the NHS due to the immaturity of the survival data at the time, but the clinical trial data have now matured. After five years, 88 percent of patients prescribed Tagrisso were still alive, versus 78 percent among patients given a placebo. As for disease-free survival, patients on adjuvant Tagrisso lived a median 65.8 months without their cancers returning, whereas patients who received placebo lived a median 28.1 months without their cancers returning.
"The information gathered during this drug's time in the CDF and further clinical studies means we can make this positive recommendation," Helen Knight, director of medicines evaluation at NICE, said in a statement.
AstraZeneca and NHS England have settled on a confidential commercial arrangement, through which AstraZeneca will sell Tagrisso to the NHS at a discounted price. The list price for a month's supply of 80 mg Tagrisso tablets is £5,770 ($7,116.60).
The US Food and Drug Administration approved adjuvant Tagrisso for early-stage EGFR-mutated NSCLC in 2020 based on data from the Phase III ADAURA clinical trial.
Shortly thereafter, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) authorized Tagrisso in the same setting through Project Orbis, an FDA program meant to allow sponsors to pursue expedited reviews in multiple countries at once.
NICE has also backed Tagrisso in the metastatic EGFR-mutated NSCLC setting.