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

The 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 lurbinecnecedin.
results showed that the researchers assessed an ORR of 35%, a DoR of 5.3 months, and an IRC assessment of an ORR of 30% and a DoR of 5.1 months.
Zepzelca is administered mainly intravenously, with a dose of 3.2 mg/m2, a feeding cycle every 21 days until the disease progresses or is intolerable lying toxic.
the most common adverse reactions (sic) leukocyte reduction, lymphocyte reduction, fatigue, anemia, neutrophil reduction, increased creatine, increased alanine transaminase, increased blood sugar levels, platelet reduction, nausea, decreased appetite, musculoskeletal pain, albumin reduction, constipation, breathing difficulties, sodium reduction, increased tinoplase, vomiting, coughing, reduced blood magnesium levels, and diarrhea.
lurbinectedin is a seaotter 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 cause tumor cells to deform, apoptosis, and ultimately reduce cell proliferation during fistic division.
August 2018, the FDA granted lurbinectedin the status of an orphan drug for the treatment of small cell lung cancer.
Zepzelca will go on sale in the U.S. in early July.
under an agreement signed at the end of December 2019, Jazz Pharma acquired Zepzelca's exclusive sales interest in the U.S. market from PharmaMar.
Green Leaf Pharmaceuticals signed a licensed research and development cooperation agreement with PharmaMar in April 2019 for Lurbinectedin, which was in Phase III, to acquire exclusive rights to the development and commercialization of the drug in China, including all indications of small cell lung cancer.
in 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 China.
small cell lung cancer is a type of lung cancer with high malignancy, rapid tumor progress and early widespread metastasis, accounting for about 15% of all lung cancer patients. Treatment options for Patients with SCLC, which developed disease progression after chemotherapy
platinum drugs, are very limited. according to the
WHO, the number of new cases and deaths of lung cancer in China reached 774,000 and 690,000, respectively, in 2018.
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