EU CHMP recommends approval of Tagrisso (osimertinib) in non-small-cell lung cancer- AstraZeneca

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Tagrisso (osimertinib), from AstraZeneca, intended for the treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) associated with a particular genetic mutation (T790M).

The safety and efficacy of Tagrisso were demonstrated in two single-arm phase II trials involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease progressed after treatment with EGFR-blocking therapies. Results from these two trials showed that a high proportion of patients (around 66%) responded and their tumour shrunk. This response appeared to be long-lasting. The benefits in terms of progression free survival and/or overall survival have not yet been determined. The most common side effects of Tagrisso are diarrhoea and skin and nail conditions such as dry skin, rash and acne.

As part of the conditional marketing authorisation, the applicant for Tagrisso must provide results from an ongoing phase III study. Until availability of full data, the CHMP will review the benefits and risks of Tagrisso annually to determine whether the conditional marketing authorisation can be maintained.

Comment: The Medicines and Healthcare Products Regulatory Agency in the UK has awarded the drug Promising Innovative Medicine status as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC.