Patients in Europe with a certain form of lung cancer could soon get access to a new, first-in-class treatment option after regulators waved through AstraZeneca’s targeted therapy Tagrisso.
The drug has been awarded conditional approval for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who carry the T790M mutation, as determined by a validated diagnostic test based on a tumour tissue sample or plasma.
Tagrisso (AZD9291, osimertinib) is the new first medicine to win clearance under the European Commission’s expedited process, after Phase II studies showed an objective response rate of 66% and median progression-free survival of 9.7 months.
It’s safety profile was also considered acceptable, the most common adverse events observed in the trials were generally mild to moderate and included diarrhoea (42%), rash (41%), dry skin (31%) and nail toxicity (25%). Warnings and precautions include interstitial lung disease and QT interval prolongation.
Welcoming the drug’s approval, Matthew Peters, Chair of the Global Lung Cancer Coalition, noted that patients with EGFR mutations and the separate T790M have disappointing responses to standard treatments, and that directing them “towards a medication such as osimertinib that is specifically designed for their pattern of mutations, offers greater prospects for durable treatment outcomes”.
Tagrisso picked up an accelerated approval in the US in November last year, and has also been available in the UK under the country’s Early Access to Medicines Scheme since December.