When will Platinib be released on the market?

Pralsetinib is an oral tyrosine kinase inhibitor targeting RET gene fusion, developed by Blueprint Medicines in collaboration with Genentech. This innovative drug has shown remarkable efficacy in treating specific types of cancer, so its launch time has attracted great attention from the global medical community and patients. According to official information from the U.S. Food and Drug Administration (FDA), platinib received accelerated approval on September 4, 2020, for the treatment of adult patients with RET fusion-positive metastatic non-small cell lung cancer (NSCLC). This marks a significant progress in RET targeted therapy in precision medicine for lung cancer.

Subsequently, the indications of platinib were gradually expanded. In December 2020, the FDA further approved it for the treatment of patients 12 years and older with advanced or metastatic medullary thyroid cancer (MTC) with RET gene mutations, especially those who require systemic treatment. At the same time, platinib has also become a new treatment option for patients with RET fusion-positive thyroid cancer (those with poor response to previous radiotherapy or systemic therapy).

Outside the United States, the European Medicines Agency (EMA) granted Platinib "priority review" status in 2021 and received EU marketing authorization in 2021. The National Medical Products Administration approved its use in the treatment of RET fusion-positive NSCLC patients in June 2022, becoming one of the first RET-targeted therapeutic drugs on the Chinese market. The rapid approval of platinib and its simultaneous advancement in many places around the world highlight its value in precision tumor treatment.

It is worth noting that Platinib adopted a "basket trial" design during its approval process, which screens by detecting RET fusion or mutation status rather than tumor origin. This precision medicine model is also becoming a new trend in the development of future cancer-targeted drugs.

Reference: https://gavreto.com/