Lubinectedin, a new drug for small cell lung cancer, has been given priority by FDA!

Compiling On February 17, pharmapar and jazz pharmaceuticals jointly announced that the FDA of the United States has accepted its application for priority review of new drug applications (NDA), seeking to accelerate the approval of lurbinectdin for small cell lung cancer (SCLC) patients who have made progress after previous platinum containing treatment FDA has set the target action date for PDUFA as August 16, 2020 Pharmamar and jazz submitted NDA in December 2019 based on phase II clinical study data from the single therapy basket trial, which evaluated the efficacy of lurbinectdin in the treatment of recurrent SCLC The results showed that the study reached the primary end point of objective response rate (ORR) and showed activity as a single drug therapy in the second-line treatment of SCLC The specific data are as follows: the orr of lurbinectdin in all patients is 35.2%, the median overall survival time (OS) is 9.3 months; the orr of sensitive patients (ctfi ≥ 90, i.e relapse within 90 days or more) is 45%, the median OS is 11.9 months; the orr of resistant patients (ctfi The orr was 22.2%, and the median OS was 5 months In addition, the disease control rate (DCR) of lurbinectdin was 68.6% in all patients, 81.7% in sensitive patients and 51.1% in drug resistant patients The total response duration (DOR) was 5.3 months in all patients, 6.2 months in sensitive patients and 4.7 months in drug resistant patients The median progression free survival (PFS) was 3.9 months in all patients, 4.6 months in sensitive patients and 2.6 months in drug resistant patients At the same time, the drug has controllable safety For patients with recurrent SCLC, there are still important unmet clinical needs Since the last new chemical topotecan was approved, the treatment environment has not changed significantly in the past 20 years SCLC accounts for 10% - 15% of all lung cancer patients It is an aggressive disease, usually diagnosed in the late stage or metastasis stage About 30000 cases are newly diagnosed in the United States every year Dr Luis Paz Ares, head of Oncology Department of the 12th Hospital of the University of ocarbor in Madrid and the main author of the study, said, "lurbinectdin has shown a new alternative to second-line treatment for small cell lung cancer, and has not made relevant progress in this regard for more than 20 years." Lurbinectdin (pm1183) is a selective inhibitor of oncogenic transcription program that most tumors depend on Along with its effect on cancer cells, lurbinectdin inhibits the transcription of oncogenes in tumor associated macrophages and downregulates the production of cytokines essential for tumor growth Transcriptional addiction or transcriptional dependence is a recognized target in cancer, many of which lack other feasible targets The drug was awarded the title of orphan drug by FDA in August 2018 Pharma Mar is a Spanish biopharmaceutical company that focuses on oncology research and development to discover molecules with antitumor activity It has developed and commercialized yondelis ® in Europe, and is developing clinical research drugs for solid cancer, including lurbinectdin, pm184 and pm14 From: pharmamar official website Jazzpharmaceuticals is an American biopharmaceutical company with advantages in the field of sleep medicine, and has expanded its research and development to the field of neuroscience Its hematology / oncology product portfolio is also growing It has been listed in the United States as sunosi (solriamfetol), xyrem (sodium hydroxybutyrate) oral solution, hematology / oncology product defitelio (sodium defibrillation injection) Agents), erwinase ® and vyxeos ® (daunorubicin and cytarabine) liposomes.