Drug Name: Sunvozertinib
CAS: 2370013-12-8
Indications: Non-small cell lung cancer
China launch date: August 22, 2023 (marketing licensee: Dizhe Pharmaceutical Co., Ltd; manufacturer: Shanghai Hequan Pharmaceutical Co.)
Formulation: Tablet, 200 mg, 150 mg
Not yet available in other countries
On April 7, 2024, the U.S. Food and Drug Administration granted breakthrough therapy designation to Sunvozertinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion (Exon20ins) mutations.
The open-label, Phase I/II, international multicenter clinical study of sunvozertinib, known as WU-KONG1, and a Phase II study started by Chinese researchers were the foundations for the breakthrough therapy designation. Both studies were presented at ESMO 2023. Data from the "Wukong 15" pooled analysis (WU-KONG15): A confirmed objective remission rate (cORR) of 78.6% was attained with sunvozertinib suvortinib monotherapy as the first-line treatment for EGFR exon20ins mutant advanced non-small cell lung cancer (NSCLC), with a median progression-free outcome in the Phase II Recommended Dose (RP2D) The 300mg group's median progression-free survival (mPFS) was 12.4 months, highlighting the efficacy of the medication as "best in class" with "high efficiency and low toxicity."
On August 22, 2023 Dizhe (Jiangsu) Pharmaceutical Co., Ltd.'s Class 1 innovative drug suvotinib was officially approved for marketing in China. The drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after prior treatment with platinum-containing chemotherapy, or who are intolerant to platinum-containing chemotherapy, and have been tested and confirmed to have epidermal growth factor receptor (EGFR) exon 20 insertion mutations (EGFR ex20ins).
Sunvozertinib, which will receive Breakthrough Therapy Designation (BTD) in China and the United States in 2020 and 2022, respectively, for the treatment of locally advanced NSCLC with EGFR exon20ins mutation, is the first nationally-created Class I new drug in the field of lung cancer to receive BTD in both China and the United States. It is the first new class I drug in the field of lung cancer to be recognized as a breakthrough therapy by both China and the US.
