FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an next generation sequencing (NGS) companion diagnostic for mobocertinib to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50 percent of EGFR Exon20 insertions.

The approval is based on results from the platinum-pretreated population in a Phase I/II trial of mobocertinib which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160mg dose. Results were presented at the 2021 American Society of Clinical Oncology from the Phase I/II trial and demonstrated a confirmed ORR of 28 percent per independent review committee (IRC) as well as a median DoR of 17.5 months per IRC, a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months per IRC.

The most common adverse reactions were diarrhoea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin and musculoskeletal pain. The prescribing information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity and diarrhoea.

“EGFR Exon20 insertion+ NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs,” commented Pasi Jänne at the Dana Farber Cancer Institute. “The approval of Exkivity (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinicall