Keystone Pharmaceuticals RET inhibitor Platinib's China listing application was accepted and included in the priority review.

Recently, China's State Drug Administration (NMPA) formally accepted the application for the listing of Pralsetinib capsules and included them in the priority review for the treatment of patients with RET fusion-positive non-small cell lung cancer (NSCLC) with platinum-containing chemotherapy.
Platini is an oral, highly selective and powerful RET single-target inhibitor developed by Blueprint Pharmaceuticals Corporation, a strategic partner of Keystone Pharmaceuticals, once a day, easy to take and more compliance.
Pharmaceuticals owns exclusive clinical development and commercial rights to Platini monodone or combined therapy in Greater China, including Chinese mainland, Hong Kong, Macau and Taiwan.
in Greater China, Blueprint Medicines Corporation has a global partnership with Roche/Genentek.
owns Platini's exclusive global licenses in Greater China (including Chinese mainland, Hong Kong, Macau and Taiwan) and markets outside the United States, as well as the right to jointly develop and commercialize Platini in the United States and Blueprint Medicines Corporation.
September 4, Platini has just received FDA approval to treat adult patients with RET fusion-positive local late stage or metastasis NSCLC.
FDA approved Platini based on data from key I/II ARROW studies.
ARROW study aims to assess platinib's safety, tolerance, and efficacy for RET fusion-positive NSCLC, thyroid cancer, and other advanced solid tumors that carry RET variants.
87 patients who had previously received platinum-containing chemotherapy, platinib patients had ORR of 57% and CR 5.7%.
70% of the 27 first-time patients who were not suitable for platinum-containing chemotherapy, with a complete remission rate of 11%.
-based bridging trial conducted in China by
Keystone Pharmaceuticals achieved the first retinal-positive NSCLC patients with platinum-containing chemotherapy in August 2019, and the last patient was admitted to the group in December of the same year.
results showed superior and long-lasting anti-tumor activity and good safety and tolerance in patients who had previously received RET fusion-positive NSCLC with platinum-containing chemotherapy, consistent with the global patient population studied by ARROW.
Program will present the results of ARROW's study of RET fusion-positive NSCLC Chinese patients at future academic conferences.
it took just two months for Keystone Pharmaceuticals to submit its NDA in China from the release of data from the results of chinese patient studies from the July key trial of global I/II ARROW.
RET fusion of positive cancer and RET mutation-positive thyroid myelin-like cancer of tumor cell differentiation and proliferation is highly dependent on the activation of RET protein, which is often referred to as "carcinogenic gene addiction", so RET-positive tumors are highly sensitive to high-selective single-target RET inhibitors.
the incidence of RET gene fusion in NSCLC patients is about 1% to 2%, in thyroid papyroid cancer (about 85% of all thyroid cancer) incidence rate is 10% to 20%.
of the RET gene mutation in thyroid myelin-like cancer is about 60%.
The current treatment for RET fusion mutant tumors is mainly the use of multi-kinase inhibitors, such as capotinib, van der Thani, due to the targeting of selectivity is not high, the efficacy is very limited and more toxic.
not only can bring strong and stable efficacy to patients with RET-positive solid tumors, but also has a low rate of adverse events above level 3, and the survival benefits are significant.
Platini has also been awarded by the FDA for breakthrough therapy for RET fusion NSCLC, which progresses after platinum-containing chemotherapy, and for RET mutation-positive thyroid myelin-like cancer that requires systematic treatment and has no alternative treatment.
The development of RET targets in the field of precision treatment of lung cancer is another huge breakthrough after targets such as EGFR, ALK, ROS1 and NTRK," said Professor Wu Yilong of Guangdong Provincial People's Hospital, lead researcher of the study.
, there is no selective RET inhibitor approved in China.
for RET fusion positive NSCLC patients, there are still huge unsolvered clinical treatment needs.
Platini in global trials and in patients with NSCLC in China, we look forward to its domestic launch and the benefits it brings to patients. Dr. Ningjun Jiang, Chairman and CEO of
Keystone Pharmaceuticals, said, "We are pleased to see that NMPA has accepted and included Pratinib's adaptation application for the treatment of RET fusion-positive NSCLC with platinum-containing chemotherapy as a priority review.
this is the third and Chinese mainland new drug applications submitted by Keystone Pharmaceuticals worldwide this year, which is a clear indication that Keystone Pharmaceuticals is accelerating on the path of a strategic transformation of commercialization.
we look forward to Platini's early domestic listing, for China's vast number of RET fusion positive NSCLC patients to bring new treatment hope.
Jianxin Yang, Chief Medical Officer, keystone Pharmaceuticals, said, "We are pleased to see Platinib demonstrate rapid and long-lasting anti-tumor activity and good safety and tolerance in clinical trials.
it is worth noting that it took only two years from our partnership with Blueprint Medicines Corporation to Platini's successful domestic filing of a listing application.
We will continue to make every effort to advance Platinib's research and development in China and more broadly evaluate the efficacy of the product in patients with RET fusion-positive NSCLC, thyroid myelin and other solid tumors without platinum-containing chemotherapy, so as to meet the clinical needs of this group of cancer patients as soon as possible."
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