GAVRETO® (pralsetinib), a precision therapy discovered by CStone Pharmaceuticals' partner Blueprint Medicines, had the first batch of prescriptions issued at Guangdong Province People's Hospital and around 100 other hospitals across China. GAVRETO is also available at around 80 pharmacies in close to 70 cities across China. With this milestone, GAVRETO, as the first approved selective RET inhibitor in China, can benefit Chinese patients.
Currently, lung cancer is ranked the highest in both incidence and mortality among all types of cancer in China, of which non-small cell lung cancer (NSCLC) represents 80% to 85% [1]. RET fusions are oncogenic drivers in one to two percent of NSCLC patients[2]. In China, about 11,000 new cases of RET fusion-positive NSCLC patients are diagnosed each year, and most of them are already in the advanced stage when diagnosed, posing great challenges to treatment.
Historically, the clinical efficacy of treatment options for RET fusion-positive NSCLC has been very limited. The approval of GAVRETO changed the treatment paradigm in this field and provides physicians with a new treatment option. GAVRETO is a selective RET inhibitor with robust and durable anti-tumor activity and has shown a high objective response rate, as well as safety and tolerability, in patients with RET fusion-positive NSCLC in the Phase 1/2 ARROW clinical study.
Dr. Yi-long Wu, Guangdong Province People's Hospital said, "Prior to the approval of GAVRETO, treatment options for patients with RET fusion-positive non-small cell lung cancer were limited. GAVRETO, a once-daily treatment option, is expected to become the standard of care for patients with RET fusion-positive NSCLC in China. I am very glad that the therapy has been approved and is starting to benefit patients."
In March 2021, the National Medical Products Administration of China approved GAVRETO (pralsetinib) capsules for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy. GAVRETO was granted approval from the U.S. Food and Drug Administration in September 2020 for the treatment of adults with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, and was soon introduced in Hainan Boao Lecheng International Medical Tourism Pilot Zone in China under a pilot program, making it the first new drug to be launched in Boao Lecheng within the same month after it was approved in the U.S.
To accelerate the commercialization of GAVRETO in China, CStone has signed strategic partnerships with Sinopharm Group, Shanghai MediTrust Health Technology, and Beijing Yuanxin Technology Group, with the goal of improving the accessibility and affordability of GAVRETO as well as supporting patient compliance.
Ms. Shirley Zhao, General Manager of CStone Greater China, said, "GAVRETO is our first innovative precision therapy to benefit patients with RET fusion-positive NSCLC in China. We will work with our partners to further improve the accessibility and affordability of GAVRETO. Meanwhile, we will continue to explore the potential of GAVRETO in additional indications. In April 2021, the NMPA accepted the New Drug Application of selective inhibitor GAVRETO with priority review designation for the treatment of patients with advanced or metastatic RET-altered thyroid cancer. We look forward to potentially benefiting more patients in the future."
References
[1] Lung cancer: New biological insights and recent therapeutic advances. Ramalingam SS, Owonikoko TK, Khuri FR,CA Cancer J Clin. 2011 Mar-Apr; 61(2):91-112.
[2] Subbiah V, Cote G J. Advances in Targeting RET-Dependent Cancers[J]. Cancer discovery, 2020, 10(4): 498-505
About RET fusion-positive NSCLC
In recent years, China has had rising lung cancer incidence. According to the latest estimates on the global burden of cancer released by International Agency f...
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