October 18, 2021

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Refractory mutant lung cancer: FDA approved the first oral therapy Exkivity

Refractory mutant lung cancer: FDA approved the first oral therapy Exkivity.  

Refractory mutant lung cancer: FDA approved the first oral therapy Exkivity



Refractory mutant lung cancer: FDA approved the first oral therapy Exkivity.  

There are many types of lung cancer, of which non-small cell lung cancer accounts for 85%. Approximately 2.2 million newly diagnosed lung cancer cases are diagnosed globally every year.

Recently, the FDA has accelerated the approval of the oral therapy Mobocertinib (Exkivity) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with EGFR exon 20 insertion mutations who have disease during or after platinum-containing chemotherapy progress.

This is the first and only currently approved oral therapy specifically targeting EGFR exon 20 insertion mutations.

At the same time, the FDA also approved next-generation sequencing (NGS) Oncomine Dx as an auxiliary diagnosis (CDX) for Mobocertinib to identify NSCLC patients with EGFR exon 20 insertion.

Refractory mutations in lung cancer that cannot be ignored

Non-small cell lung carcinoma (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of all lung cancers.

According to data released by the World Health Organization, there are approximately 2.2 million newly diagnosed lung cancer cases worldwide each year, and the death toll exceeds 1.8 million, making it the world’s highest mortality rate of cancer. In China, the new incidence and death rate of lung cancer ranks first in the world.

Metastatic NSCLC with positive insertion of epidermal growth factor receptor (EGFR) exon 20 accounts for about 1-2% of NSCLC patients. It is a refractory mutation and is more common in Asian populations.

Due to the large base of NSCLC patients, EGFR exon 20 insertion mutations are not “uncommon”. Moreover, such patients are usually insensitive to EGFR receptor tyrosine kinase inhibitor (TKI) treatment and have a poor prognosis.

Currently, there is no approved targeted therapy for lung cancer patients with EGFR exon 20 insertion mutations, and patients urgently need new treatment options.

Oral targeted therapy: Mobocertinib

Mobocertinib is an oral small molecule tyrosine kinase inhibitor (TKI) that can selectively target the epidermal growth factor receptor (EGFR) exon 20 insertion mutation.

Previously, Mobocertinib had obtained breakthrough therapy designation, fast track designation and priority review qualifications granted by the FDA.

Continuous relief for one and a half years! Innovative therapies bring new hope

This FDA approval is based on the results of the Phase 1/2 EXKIVITY clinical trial.

The trial enrolled 114 NSCLC patients with EGFR exon 20 insertion mutations who had previously received platinum therapy.

The results announced at the 2021 American Society of Clinical Oncology (ASCO) annual meeting showed:

Among 114 patients, the Mobocertinib treatment group achieved an objective response rate of 28%.

The median overall survival (OS) of patients in the treatment group was 24 months, the median duration of remission was 17.5 months, and the median progression-free survival (PFS) was 7.3 months.

NSCLC patients with EGFR exon 20 insertion mutations are not sensitive to traditional EGFR TKI therapy and have limited clinical benefit.

The approval of the targeted therapy Mobocertinib brings a durable oral therapy for patients with such refractory mutations.

Reference

https://www.takeda.com/newsroom/newsreleases/2021/takeda-exkivity-mobocertinib-approved-by-us-fda/haoeyou.com/zhongliu_aizheng/feiai/20210918/6744.html

(source:internet, reference only)


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