The innovative targeted drug RET inhibitor Pralsetinib Extended Adaptation has been approved by the FDA to treat thyroid cancer

Recently, the U.S. Food and Drug Administration (FDA) accelerated the approval of the innovative target drug RET inhibitor pralsetinib expansion of adaptive disease for the treatment of patients with thyroid cancer carrying THET variant.
is another important milestone in the field of precision cancer treatment.
, developed by Blueprint Medicines, is an oral, daily, powerful, highly selective RET inhibitor.
Currently, the FDA has approved three adaptations to the drug: adult patients with RET fusion-positive non-small cell lung cancer (NSCLC), advanced or metastatic RET mutated thyroid myelin cancer (MTC) patients over 12 years of age who require systemic treatment, and patients with radioactive iodine refragective advanced or metastatic RET fusion-positive thyroid cancer.
, Platini has been awarded a "breakthrough therapy" by the FDA.
it is understood that Platini's interest in the development and commercialization of Greater China is owned by Keystone Pharmaceuticals.
At present, China's State Drug Administration has accepted Platini as a national 1.1 new drug market application on September 4 this year, and included it in the priority review, for the treatment of platinum-containing chemotherapy RET fusion positive non-small cell lung cancer patients.
It is worth mentioning that on September 30 this year, Platini successfully introduced the Hainan Free Trade Port Boao Lecheng International Medical Tourism Advance Zone, which is the only landing market for the drug outside the United States, and domestic patients can apply for use in Boao Le City as a priority.
In addition, Keystone Pharmaceuticals has conducted registered clinical studies in China on platinib's first-line treatment of RET-fused NSCLC and thyroid myelin-like cancer, while platinib's efficacy in other advanced solid tumors with RET variants is being further explored.
currently, Platini has demonstrated extensive and long-lasting anti-tumor activity in patients with advanced solid tumors with a variety of RET mutations, including thyroid myelin, thyroid, and non-small cell lung cancer.
expect the innovative target drug RET inhibitor Platinib to be approved for market in China as soon as possible, benefiting more patients as soon as possible.
: RET inhibitors to achieve a major breakthrough in thyroid cancer in China, the incidence of thyroid cancer increased year by year.
related reports show that the incidence of thyroid cancer is about 146 per 100,000 people, of which the incidence of thyroid myelin cancer (MTC) accounts for about 2% to 4% of thyroid cancer, its malignancy is high, prone to distant metastasis, and the efficacy of late-stage patients is not good.
about 60% of thyroid myelin-like cancers detect reT gene mutations, and the proportion of RET mutations in advanced patients is as high as 90%.
RET gene mutation can be described as the "source of all evils" of thyroid myelin-like cancer, for the presence of 90% RET mutation of advanced thyroid myelin-like cancer, precise suppression of RET mutation will be essential, which will further improve tumor remission rate, improve patient prognostic.
The "birth" of the innovative target drug Platinib breaks the multi-target "casting" of thyroid myelin cancer (MTC), which can highly selectively and accurately combat the RET mutation gene, has a broader and lasting anti-tumor effect on patients with advanced thyroid myelin cancer (MTC) with RET mutations, and is expected to overcome and prevent clinical resistance by inhibiting primary and secondary mutations.
: RET fusion of non-small cell lung cancer in addition to thyroid cancer, in the field of lung cancer, Platini will also provide new life for RET fusion of non-small cell lung cancer patients.
, EGFR, ALK, ROS1 and other drive gene mutations have been widely used in this field, and targeted drugs targeting these drive genes have been approved for market.
RET fusion is a newly discovered lung cancer-driven gene that accounts for about 1-2% of RET fusion patients in non-small cell lung cancer, which is more common in non-smokers.
estimates that about 11,000 new RET-positive lung cancer cases are reported in China each year, based on the huge number of patients with lung cancer.
for patients with RET mutations, patients are less likely to have other carcinogenic drive genes and are mostly diagnosed with advanced stages of the disease, which poses a significant challenge to diagnosis and treatment.
, the standard treatment of RET fusion non-small cell lung cancer is still dominated by chemotherapy, but the efficacy is not ideal, there is still a huge unsoponsed clinical treatment needs.
platinib, a highly selective RET inhibitor developed specifically for patients with RET gene variant tumors, will provide new life for PATIENTs with RET fusion non-small cell lung cancer.
As a biopharmaceutical company focused on the development and commercialization of innovative oncology immunotherapy and precision therapy drugs, Keystone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercialization.
, Cornerstone Pharmaceuticals has established a rich product pipeline of 16 tumor candidates, five of which are in critical clinical trials or registration stages.
with an experienced management team, extensive pipelines, a business model focused on clinical development and ample capital, Cornerstone Pharmaceuticals' vision is to become a globally renowned biopharmaceutical company leading the way in the fight against cancer.
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