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On September 15, Takeda announced that the FDA has accelerated the approval of Exkivity (mobocertinib) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adults who carry EGFR exon 20 insertion mutations and undergo disease progression after platinum-based chemotherapy.
Patient
.
This is the first oral therapy approved in the United States for EGFR Exon20 insertion mutations
EGFR mutations are common gene mutations in patients with non-small cell lung cancer, accounting for about 10% to 15%.
Among Asian populations, this value is about 40% to 50%
.
EGFR exon 20 insertion mutations account for approximately 9% of all EGFR-mutant non-small cell lung cancer patients
It is precisely because of the urgent situation that no medicine is available, amivantamab obtained accelerated FDA approval with a phase I study of only 81 patients
.
Similarly, mobocertinib won FDA approval this time with data from a small-scale phase I/II clinical trial (NCT0271611)
The safety of Mobocertinib is controllable.
The most common treatment-related adverse events (TRAEs) include diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), and decreased appetite (32%) , Dry skin (30%) and vomiting (30%)
.
TRAEs of grade 3 and above (≥5%) were diarrhea (21%)
Mobocertinib has obtained breakthrough therapy qualifications granted by FDA and CDE at the same time
.
On May 24 this year, CDE also accepted Takeda's new drug marketing application submitted in China based on the Phase I/II study, and granted priority review qualifications
Note: The original text has been deleted
