Amivantamab plus lazertinib can be used, within its marketing authorisation, as an option for untreated advanced non-small-cell lung cancer (NSCLC) in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
Amivantamab and lazertinib can only be used if the company provides them according to their commercial arrangements.
Amivantamab plus lazertinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Amivantamab plus lazertinib must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that amivantamab plus lazertinib provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations is osimertinib alone, or osimertinib plus pemetrexed and platinum-based chemotherapy (from now, osimertinib plus chemotherapy).
Clinical trial evidence shows that amivantamab plus lazertinib increases how long people have before their condition gets worse and how long people live compared with osimertinib alone. But how well amivantamab plus lazertinib works compared with osimertinib plus chemotherapy is uncertain because of the limitations of the methods used to compare them.
There are uncertainties with some of the assumptions used for long-term extrapolations in the economic model. But the most likely cost-effectiveness estimates for amivantamab plus lazertinib are within the range that NICE considers an acceptable use of NHS resources. So, it can be used.