NEWS

Lurbinectedin, an innovative anti-tumor drug, was approved for clinical use in China.

Release time:

2020-09-03 09:45

Following innovative anti-tumor drugsLurbinectedinThis year6Approved in the United States for the treatment of metastatic disease progression during or after chemotherapy with platinum-based drugs.SCLCAfter adult patients, according8Month27Japan China National Food and Drug Administration Drug Evaluation Center (CDE) of the latest announcement, an innovative anti-tumor drug introduced by Green Leaf Pharmaceuticals.LurbinectedinApproved clinically in China, it is intended to be used for small cell lung cancer after failure of first-line platinum-containing chemotherapy (SCLC）PatientThe treatment.

SCLCIs one of the more common types of lung cancer, accounting for about bronchogenic lung cancer15%-20%. Although compared to other types of lung cancer,SCLCaccounts for a low proportion of all lung cancers andThere are着better chemotherapy and radiotherapy, but unfortunately, most ofSCLCPatients after initial treatmentAllThere will be relapse and drug resistanceSexand becauseSCLCCancer cells grow rapidly, easy to spread the characteristics of metastasis, soWhenSCLCThe patient wasAt the time of diagnosis,The tumor is likely to have spread widely and is often difficult to cure,Patient5The annual survival rate is about5%The mortality rate is high.

Lurbinectedinis an ascidin derivative that isRNAPolymeraseIIThe inhibitor is also self.1996The first year sinceFDAApprovedSCLCNew drugs for second-line treatment.LurbinectedinThe mechanism of action is:RNAPolymeraseIIoften over-activated during transcription in tumor cells,withDNAThe combination of minor grooves on the double helix structure,The tumor cells are distorted during mitosis and eventually apoptosis.,This in turn reduces cell proliferation.

The approval is primarily based on aLurbinectedinmonotherapy105Cases of disease progression after platinum-based chemotherapySCLCClinical data from an open-label, multicenter, single-arm study in adult patients (including platinum-sensitive and platinum-resistant patients). The results of the study showed that the total effective rate assessed by the researchers (ORR) reach35%, duration of mitigation (DoR) the median is5.3months; Independent Review Board (IRC) assessedORRReach30%,DoRThe median is5.1Months.

LurbinectedinExcept this year.6In addition to its approval for marketing in the United States in January, the drug has recently been prioritized in Australia and Singapore through a special access mechanism.SCLCpatients. in addition,LurbinectedinIt has also been successively obtained in the United States, the European Union, Switzerland, Australia and other countries and regions for the treatment of small cell lung cancer (SCLC) orphan drug qualification.

This timeLurbinectedinClinical approval in China means that this product is about to enter the clinical development stage in China.,BelieveLurbinectedinPromise for small cellslung cancer(SCLC)New treatment options for patients. At the same time,LurbinectedinOutside, there are many worldwide.PD-1Inhibitor approved for treatmentSCLCpatients. In addition, there are someSCLCNew therapies are being studied, includingRNAPolymeraseIIinhibitors,CDK4/6Inhibitors, TargetedTIGIT,Lag3,CTLA-4andOX40checkpoint inhibitors, etc.,This undoubtedly makesSCLCPatients have more hope.

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