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NICE U-turns to approve AstraZeneca's Tagrisso in two new lung cancer indications

Published on 11/09/20 at 11:24am

NICE has announced the recommendation of AstraZeneca’s Tagrisso (osimertinib) for routine use on the NHS in England and Wales in two new lung cancer indications. The first is in locally advanced or metastatic epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC).

The decision was based on clinical data demonstrating the therapy’s benefit in progression-free survival compared to current standard of care of a daily oral dose of NICE-approved afatinib, erlotinib, gefitinib or dacomitinib.

It marks a reversal of NICE’s original decision to reject the drug due to concerns over its cost-effectiveness, now that AstraZeneca has offered a new commercial arrangement.

The drug watchdog said that the “majority” of the 1,800 patients in England with advanced EGFR-positive NSCLC, which represents roughly 10% of all lung cancer cases, will now be able to access the therapy on the NHS.

In tandem, NICE also revealed that it has recommended Tagrisso for the second-line treatment of locally advanced or metastatic EGFR-positive NSCLC with the T790M mutation, moving availability from the Cancer Drugs Fund to routine NHS use.

“We are pleased to be able to recommend osimertinib as a first- and second-line treatment option to patients with a relatively rare form of lung cancer,” explained Meindert Boysen, Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at NICE. “Osimertinib has shown the ability to improve the lives of patients with this devastating disease, and is likely to extend their time with loved ones. I know this news will be welcomed by patients and their families and carers.”

Final guidance on these two decisions is expected in October this year.

Matt Fellows

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