NEWS

New Choice for Cancer Treatment-China's First Selective RET Inhibitor Pratinib Approved for Marketing

Release time:

2021-04-01 16:39

Recently, the State Drug Administration approved pratinib(Pralsetinib) Capsule (trade name: PuJiHua) as a national class innovationDrug marketing application for the treatment of transfected rearranged genes that have previously received platinum-containing chemotherapy.(RET)Fusion-positive locally advanced or metastatic NSCLC (NSCLC) Adult patients. This is the first selective approved by ChinaRETinhibitors.

RETIs a proto-oncogene, first discovered in1985Year, located in10Chromosome number, there is21Exons.RETEncodedRETProtein is a receptor tyrosine kinase that exists on the cell membrane (RTK), when the growth factor binds to the extracellular region of the receptor, it triggers a series of intracellular chain chemical reactions, causing cells to divide, mature and perform corresponding functions.

With the gradual progress of research, it has been found that the occurrence of a variety of diseases andRETgene mutations, whichRETgene fusion inNSCLCThe incidence in patients is approximately1%～2%In papillary thyroid carcinoma (PTCThe incidence in) is10%, Medullary thyroid carcinoma (MTC) MediumRETThe incidence of gene mutations is approximately60%Other occurrencesRETVariant tumors include meningioma, esophageal adenocarcinoma, breast cancer, colorectal cancer, etc. Therefore,RETGenetic variation becomes"Unlimited cancer"An important target for therapy.

In recent years, there have beenRETThe fusion of targeted drugs inNSCLCEfficacy and safety studies were conducted in patients. Pratinib is a potent, highly selective targeted carcinogenicRETVariation of small molecule kinase inhibitors, only need to take once a day, with good compliance, wasFDAGrant of treatment for progression after platinum-containing chemotherapyRETfusion positiveNSCLCand those who require systemic treatment and have no alternative treatment optionsRETBreakthrough therapy eligibility for mutation-positive medullary thyroid cancer.

in addition,Cornerstone Pharmaceuticals in China launched a globalARROWstudy's Chinese registered bridging trial, in2019Year8The first patient was administered in the same year.12The month finished finally.1patients into the group.Thetrials were included37patients, median age54Years old (range:26-77years). The results of the trial showed that the overall response rate of patients treated with pratinib (ORR)56%, in which3%Achieved complete remission (CR), Disease control rate (DCR) reach97%. As2021Year1months, median treatment duration6.1months (range:0.9~9.4）；18The median time to first remission for patients in remission was1.9months, of which89%(16/18) are still on treatment, the median duration of remission (DOR) is not yet mature,6monthsDORThe rate is83%. Security, although10.8%of patients discontinued due to adverse events, but there were no cases of patient discontinuation and death due to impratinib treatment.

Overall, pratinib in platinum-containing chemotherapyRETfusion positiveNSCLCChinese patients showed superior and durable anti-tumor activity, safety and good tolerance, no treatment termination or death caused by adverse events related to pratinib, for China.RETPatients with positive tumors offer a new treatment option.

Pratinib as China's first selectiveRETInhibitors approved for listing, will make more.ofChinese patients benefit.

O LORD, O LORD, O LORD, O LORD, O LORD, O LORD, O LORD.