Today, Takeda announced that the U.
FDA has granted priority review for its new drug application for mobocertinib (TAK-788) for the treatment of metastatic non-small cell lung cancer (NSCLC) with positive EGFR exon 20 insertion.
These patients had previously received platinum-containing chemotherapy.
The press release states that mobocertinib is the first oral therapy specifically designed to selectively target the insertion of EGFR exon 20.
Non-small cell lung cancer is the most common type of lung cancer.
According to statistics from the World Health Organization, it accounts for approximately 85% of newly diagnosed lung cancer cases worldwide each year.
Metastatic NSCLC patients with positive EGFR exon 20 insertion account for about 1-2% of NSCLC patients, and the disease is more common in Asian populations.
Such patients have a worse prognosis than other EGFR mutations.
There is currently no approved targeted therapy for this genetic variant, and existing EGFR tyrosine kinase inhibitors and chemotherapy provide limited benefits for these patients.
Mobocertinib is a potent oral small molecule tyrosine kinase inhibitor specifically designed to selectively target EGFR exon 20 insertion mutations.
It was granted a breakthrough therapy designation by the FDA in April 2020 for the treatment of patients with EGFR exon 20 insertion-positive metastatic NSCLC who have progressed during or after platinum-containing chemotherapy.
In October 2020, mobocertinib was designated as a breakthrough therapy product by the Center for Drug Evaluation (CDE) in China.
The priority review qualification is awarded based on the results of Phase 1/2 clinical trials.
The previously published results showed that among 114 patients, according to the evaluation of the independent data monitoring center, mobocertinib reached a confirmed objective remission rate of 28%, with a median remission.
The duration was 17.
5 months, and the disease control rate reached 78%.
▲Phase 1/2 clinical trial results of Mobocertinib (picture source: reference )
 Takeda Announces US FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer.
Retrieved April 27, 2021, from .
[w] Takeda Presents Positive Results For Mobocertinib in Patients with EGFR Exon20 insertion+ mNSCLC Who Received Prior Platinum-based Chemotherapy.
Retrieved January 28, 2021, from