Keytruda® gets the green light from NICE for untreated lung cancer

The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending that Keytruda® (pembrolizumab), in combination with Alimta® (pemetrexed) and platinum chemotherapy, should be available through the Cancer Drugs Fund as a treatment option for certain patients with untreated non-small-cell lung cancer (NSCLC).

NICE estimates that more than 3000 patients in England may be eligible for this combination treatment.

The approval stems from data obtained from the KEYNOTE-189 trial, which demonstrated a significant improvement in overall survival and progression-free survival for patients (specifically untreated, metastatic, non-squamous NSCLC adult patients whose tumours have no EGFR– or ALK-positive mutations) randomized to pembrolizumab in combination with pemetrexed and platinum chemotherapy compared with pemetrexed and platinum chemotherapy alone.

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NICE stated that the combination has the potential to be cost effective and was likely to extend life, making it eligible for use on the Cancer Drugs Fund. However, NICE stated that it will not yet be considered for routine NHS use as further evidence is needed on the benefits of the treatment.

This combination therapy will be available to NHS patients in England immediately. Subject to appeal, NICE’s final guidance will be published in January – just 8 months after the appraisal began.

Pembrolizumab is administered every 3 weeks by intravenous infusion. NICE noted that the regular price of a 200mg infusion is £5,260 ($6792), but the company offered the NHS a confidential discount.