FDA grants lurbinectin (PM1183) orphan drug title

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FDA) awarded the title of lurbinectedin (PM1183) orphan drug, data show that the drug treatment after chemotherapy progress small cell lung cancer (SCLC) patients, the overall remission rate (ORR) of the disease (ORR) reached 39.3%, the median total survival (OS) 11.8 monthsstudy recruited 68 patients with a median age of 60.5 years (range: 40-83 years), of whom 43 were male and 25 were femaleThe patients' ECOG physical status score was 0 (n-21), 1 point (n-43), and 2-point (n-4)The median number of sites or organs affected by the patient's lesions is 3 (range: 1-5)68% of all patients had large tumors, and one patient was identified as having a central nervous system metastatic lesions at the beginning of treatmentThe median treatment the patient has previously received is 1 (range: 1-2)62% of patients with complete or partial remission (PR) had a complete or partial remission (PR) in previous treatments, and 12 patients (17%) had a treatment response to disease stabilization (SD)treatment, patients received a single dose of 3.2 mg/m 2, infusion time of 1 hour, once every 3 weeksThe primary endpoint syil forstudies was ORR, and the secondary end points were mitigation duration, disease-free survival (PFS), total lifetime (OS), and safetyCurrently, Lurbinectedin is currently conducting a phase III clinical study for the treatment of non-small cell lung cancer patients worldwide, codenamed THE ATLANTIS study (NCT02566993), which mainly recruits patients with small cell lung cancer (SCLC) who have failed after first-line platinum chemotherapy, and studies the efficacy of the combined Dojobistar comparison researchers in Lurbinectedin (cyclophosamide, polyjupic, and neo-base, etc.)