The National Institute for Health and Care Excellence (NICE) has published a positive recommendation for Takeda’s EXKIVITY (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD).1,2
In March 2022, Great Britain was the first country outside of the US to grant a conditional marketing authorisation to mobocertinib, a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to target EGFR Exon 20 insertion mutations.3 This milestone was hailed as ‘game-changing’ by NHS England at the time.4
Angela Terry, Chair of EGFR Positive UK, said: “This positive recommendation is fantastic news for patients. Particularly as they have previously faced frustration and isolation due to the limited treatment options available for this aggressive disease. Having a medicine specifically designed to tackle their type of cancer will give patients the much-needed hope of improved outcomes and increased confidence that the management of their disease is catching up with other types of lung cancer. We are pleased that Takeda was able to work closely with NICE and NHS England to demonstrate the value of mobocertinib and enable much needed access for patients”
Professor Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, commented: “Mobocertinib offers the patient and clinical community a significant step-change in the battle against this rare disease; not only as a proven effective targeted treatment but one that can be taken orally at home – providing enhanced patient experience and reducing the number of required hospital visits. This positive decision from NICE means that clinical management of this devastating type of lung cancer is brought more in line with other forms of the disease where targeted treatments are already routinely available. Now is the time to ensure patients are effectively diagnosed, through optimising biomarker testing for this specific mutation.”
References
- National Institute for Health and Care Excellence (NICE). Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy [ID3984]. https://www.nice.org.uk/guidance/indevelopment/gid-ta10881 Accessed: November 2022
- EXKIVITY (mobocertinib) Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/13468/smpc#gref Accessed: November 2022
- NHS England. NHS fast tracks new ‘gamechanging’ drug for lung cancer. https://www.england.nhs.uk/2022/03/nhs-fast-tracks-new-gamechanging-drug-for-lung-cancer/ Accessed: November 2022
- MHRA. Project Orbis Marketing Authorisations. https://www.gov.uk/guidance/guidance-on-project-orbis#overview-of-orbis-project-approvals Accessed: November 2022
