Alis Medical's third-generation EGFR-TKI plans to be included in breakthrough treatment products

ArticleMedicine Guanlan

On November 23, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the third-generation EGFR-TKI vometinib mesylate tablets of Allis Pharmaceuticals will be included in the breakthrough treatment product, and the proposed indication is : First-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) replacement mutation

Vometinib mesylate (trade name: Ivesa) is a category 1 innovative drug independently researched and developed by Iris Pharmaceuticals.

Public information shows that the uniqueness of vometinib as the third-generation EGFR-TKI is reflected in four aspects: First, it has dual-activity and differentiated characteristics.

This time, vometinib is planned to be included in the breakthrough treatment category, and is the first-line treatment of NSCLC for the indications

At the beginning of November, Allis Pharmaceuticals announced that vomitinib had reached the primary study endpoint of progression-free survival (PFS) in the phase 3 clinical study FURLONG

In addition to the above two indications that have been approved and planned to be included in the breakthrough treatment category, the China Phase 3 Registered Clinical Study FORWARD for the adjuvant treatment of EGFR mutation-positive stage II-IIIA NSCLC patients with vomitinib has been published in It was officially launched in April this year

It is worth mentioning that in June this year, Allis Pharmaceuticals has reached an exclusive overseas licensing cooperation agreement with ArriVent Biopharma

Reference materials:

[1] Center for Drug Evaluation of China National Medical Products Administration.

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