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NICE Approves Takeda's Exkivity for EGFR Exon 20 Insertion-Positive NSCLC

NEW YORK – The UK's National Institute for Health and Care Excellence on Wednesday recommended approval of Takeda's Exkivity (mobocertinib) for patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

NICE issued a final draft guidance recommending the treatment based on results from a single-arm Phase I/II study, in which the median investigator-assessed progression-free survival was 7.33 months and median overall survival was 23.95 months among NSCLC patients with EGFR exon 20 insertions who were previously on platinum-based chemotherapy.

NICE also considered real-world evidence submitted by Takeda to determine whether Exkivity improved outcomes for this subset of patients. These comparisons suggested that Exkivity improved survival by more than three months compared to immunotherapies and docetaxel with or without Boehringer Ingelheim's Ofev (nintedanib).

In addition to this evidence, Takeda's willingness to provide Exkivity at a confidential discount also helped cinch NICE's decision. The list price for Exkivity is £7,751 ($9,211) for a pack of 112 40mg capsules, however Takeda will provide the drug to the National Health Service (NHS) through a patient access program at an undisclosed price. In NICE's budget analysis, which factored in the confidential discount, it found that the incremental cost-effectiveness ratio was "markedly below" £50,000 per quality-adjusted life-year (QALY) gained. The agency concluded that the drug was cost-effective and an acceptable use of NHS resources.

In March, the NHS made Exkivity more widely available to NSCLC patients who have EGFR exon 20 insertion mutations while NICE completed its assessment of the drug. NICE's decision to recommend the drug will ensure continued access.

The US Food and Drug Administration approved Exkivity for the same indication last September, along with Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic.