FDA approves new drug for small cell lung cancer! Green Leaf Pharmaceuticals has interest in China

, June 17 (Xinhua) -- Jazz Pharmaceuticals/PharmaMar announced on June 15 that the FDA has accelerated the approval of Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer, which progresses after chemotherapy for platinum drugsThe FDA's approval is based primarily on open label, multicenter, single-arm studies of objective response rates (ORR) and response duration (DoR) data for platinum-sensitive and platinum-resistant adult patients whose disease progression after chemotherapy was treated with a single-drug lurbinecnecedinThe results showed that the researchers assessed an ORR of 35%, A DoR at 5.3 months, and iRC assessed an ORR of 30% and ADoR for 5.1 monthsZepzelca is administered mainly intravenously, with a dose of 3.2 mg/m2, a feeding cycle every 21 days until the disease progresses or is intolerablely toxicThe most common (-20%) adverse reactions ofleukocyte reduction, lymphocyte reduction, fatigue, anemia, neutrophil reduction, increased creatinine, increased alanine transaminase, increased blood sugar levels, decreased platelets, nausea, decreased appetite, musculoskeletal pain, decrease in albumin, constipation, breathing difficulties, sodium reduction, increased tucone, vomiting, coughing, blood level smaller, and diarrheaLurbinectedin is a sea otter derivative, an inhibitor of RNA polymerase II, which can bind to the small grooves in the double helix structure of DNA, inhibit RMG1 and RMG2, and maketumorscells deformed, apoptosis, and ultimately reduced cell proliferation during fissionIn August 2018, the FDA granted lurbinectedin the status of an orphan drug for the treatment of small cell lung cancerZepzelca will be available in the U.Sin early JulyUnder an agreement signed at the end of December 2019, Jazz Pharma acquired Zepzelca's exclusive sales interest in the U.Smarket from PharmaMarIn April 2019, Green Leaf Pharmaceuticals signed an authorized research and development cooperation agreement with PharmaMar, which was in Phase III, to acquire exclusive rights to develop and commercialize the drug in China, including all indications of small cell lung cancerIn addition, Green Leaf Pharmaceuticals has the right to require PharmarMar to make a technical transfer of the drug during the agreement, and Green leaf pharmaceuticals to manufacture the drug in ChinaSmall cell lung cancer is a type of lung cancer with high malignancy, rapid tumor progress and widespread metastasis, accounting for about 15% of all lung cancer patients Treatment options for Patients with disease progression after chemotherapy for platinum drugs are very limited The number of new cases and deaths from lung cancer in China reached 774,000 and 690,000, respectively, in 2018, according to WHO data