Takeda's Exkivity gains NICE backing for EGFR

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended 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). The drug is being commercialized by Japan’s largest drugmaker Takeda (TYO: 4502).

Granted conditional approval by the Medicines and Healthcare products Regulatory Agency (HRA) in March 2022, Great Britain was the first country outside of the USA to grant an authorization to mobocertinib, a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to target EGFR Exon 20 insertion mutations. This was viewed as a significant milestone and hailed as ‘game-changing’ by NHS England at the time. It also overturns the draft negative decision published within the Appraisal Consultation Document (ACD) in August 2022.

Exkivity is part of what Takeda regards as a “first wave” of around a dozen emerging drugs which represent the output from major investments in R&D and acquisitions. Peak revenue potential for Exkivity could be up to $600 million in the NSCLC indication.