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Lurbinectedin is an inhibitor of RNA polymerase II that selectively inhibits the transcription of cancer-causing genes on which multiple tumors depend, as well as the transcription of tumor-related macrophages and the production of cytokines that are critical to tumor growth.
June, the U.S. Food and Drug Administration (FDA) accelerated approval of the drug for use in the U.S. to treat adult patients with relapsed small cell lung cancer who develop the disease after receiving chemotherapy for platinum drugs.
Lurbinectedin's ORR reached 35%, and DoR's median 5.3-month Lurbinectedin was approved in the United States based on open label, multi-center, single-arm clinical data from SCLC adult patients (including platinum-sensitive and drug-resistant patients) who developed the disease after chemotherapy with a Lurbinectedin single drug.
results showed that the researchers assessed a total efficiency (ORR) of 35 per cent, a median mitigation duration (DoR) of 5.3 months, an independent review committee (IRC) of 30 per cent of ORR and a median DoR of 5.1 months.
addition to being approved in the United States, Lurbinectedin recently adopted a special access mechanism to give priority to patients in Australia and Singapore.
, the drug has been approved for orphan drugs for small cell lung cancer in the United States, the European Union, Switzerland and Australia.
provide innovative treatments for SCLC patients in China Lung cancer is one of the most morbid and mortality cancers in both globally and in China.
2018, the number of new cases and deaths from lung cancer in China reached 774,000 and 690,000, respectively, according to the World Health Organization.
cell lung cancer is a more invasive and difficult type of lung cancer, accounting for about 15% of all lung cancer patients.
progress in this area has been slow, with a very limited number of effective listed drugs.
In April 2019, Greenlee Pharmaceuticals and PharmaMar reached a authorized research and development cooperation agreement, which granted Lurbinectedin exclusive rights to develop and commercialize all adaptations, including small cell lung cancer, in China, and to require PharmaMar to transfer the drug's technology, which is produced by Greenlead Pharmaceuticals in China.
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