AstraZeneca's Tagrisso has become the first medicine to be put forward by the National Institute for Health and Care Excellence for the new Cancer Drugs Fund as more data is collected on its effectiveness.
In a Final Appraisal Determination the cost regulator is recommending Tagrisso (osimertinib) as an option for use within the CDF to treat NHS patients in England who have epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), whose disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor (TKI).
Every year in the UK, more than 45,500 people are diagnosed with lung cancer. About 87 percent of cases are NSCLC, and around 12 percent of people with NSCLC have tumours with EGFR mutations. Most patients with EGFR mutation-positive NSCLC develop resistance to existing targeted therapies (EGFR TKIs) because of a secondary mutation called T790M, and typically relapse after around one year of treatment, highlighting the urgent need for new treatment options.
Tagrisso was the first drug to win expedited approval in Europe in February this year, on the back of Phase II data showing an objective response rate of 66 percent and median progression-free survival of 9.7 months. On the safety side, the most common adverse events observed in the trials were generally mild to moderate and included diarrhoea (42 percent), rash (41 percent), dry skin (31 percent) and nail toxicity (25 percent).
"We are very proud that NHS patients in England now have access to osimertinib," said Lisa Anson, Country President, AstraZeneca UK and Ireland. "This is a breakthrough medicine with one of the fastest development programmes in pharmaceutical history. Now it is the first medicine to enter the newly reformed Cancer Drugs Fund, which is specifically designed to ensure earlier access to breakthrough cancer treatments".
"This is a great example of partnership between clinicians, AstraZeneca, the Department of Health, NICE, NHS England and other stakeholders to ensure that UK patients gain access to an innovative medicine while further data are gathered," she added.
"For the first time, we are able to give patients access to a promising new cancer treatment whilst more evidence is gathered on its effectiveness. This is the system working as it should," noted Professor Carole Longson, director of the health technology evaluation centre at NICE.