Mobocertinib Receives Positive NICE Opinion for Previously Treated EGFR Exon 20 Insertion–Mutated NSCLC

The National Institute for Health and Care Excellence has given a positive opinion of mobocertinib as a treatment for previously treated advanced non-small cell lung cancer with EGFR exon 20 insertion mutations.

The National Institute for Health and Care Excellence (NICE) has recommended mobocertinib (Exkivity) as a therapy for patients with for advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion gene mutations that was previously treated with platinum-based chemotherapy, according to a press release from NICE.1

The regulatory organization published the final draft of the guidance recommending the targeted therapeutic after over 100 patients with advanced lung cancer were said to have benefitted from treatment. Real-world, indirect comparisons of mobocertinib with immunotherapy agents and docetaxel (Taxotere) with or without nintedanib suggested that the agent increased survival, with an independent committee reporting an increase in overall survival by more than 3 months. Clinical trials have also indicated that the agent was well tolerated by patients.

“I’m delighted that we have been able to recommend this innovative treatment for patients in England with this rare and aggressive form of lung cancer,” Helen Knight, interim director of medicine evaluation at NICE, said in a press release. “This is the first treatment approved by NICE that targets this specific gene mutation in people with advanced [NSCLC]. The evidence shows it not only extends people’s lives but also extends how long people have before their cancer gets worse.”

Mobocertinib was granted approval by the FDA for the treatment of patients with EGFR Exon 20 insertion-positive NSCLC in September 2021.2 The FDA based its approval on results from a phase 1/2 trial (NCT04535557) presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Data from that trial indicated that mobocertinib demonstrated a confirmed objective response rate of 35% (95% CI, 26%-45%) and had a safety profile that was consistent with the known profiles of other EGFR tyrosine kinase inhibitors.


  1. Targeted treatment for rare form of aggressive lung cancer gets NICE approval. News release. National Institute for Health and Care Excellence. November 16, 2022. Accessed November 21, 2022.
  2. Takeda’s EXKIVITY™ (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR Exon20 insertion+ NSCLC. News release. Takeda Pharmaceutical Company Limited. September 15, 2021. Accessed November 21, 2022.