Luye Pharma Group's partner PharmaMar announced that the U.S. Food and Drug Administration (FDA) has approved Lurbinectedin for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression, after platinum-based chemotherapy. Lurbinectedin was approved under “Accelerated Approval” based on Overall Response Rate (ORR) and Duration of Response (DoR). Luye Pharma is working together with PharmaMar to develop the drug in China.
The FDA approval of Lurbinectedin is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with relapsed SCLC. The data showed that in relapsed SCLC, Lurbinectedin demonstrated an ORR of 35 percent and a median DoR of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC).
Of all types of lung cancer, SCLC is more invasive, progresses faster and metastasizes earlier, accounting for approximately 15% of all lung cancer incidences. There are very limited treatment options available for SCLC patients with disease progression after receiving platinum-based chemotherapy. According to the World Health Organization, the number of new lung cancer cases and deaths from lung cancer in China was about 774,000, and 690,000 in 2018 respectively.
Lurbinectedin is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, Lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
In April 2019, Luye Pharma and PharmaMar entered into a license development and commercialization agreement with respect to Lurbinectedin. Pursuant to the terms of the Agreement, Luye Pharma will have the exclusive rights to develop and commercialize Lurbinectedin for Small Cell Lung Cancer and all other indications in China. In addition, Luye Pharma will have the right to request the transfer of the technology for the manufacture of Lurbinectedin in China.
In addition to receiving the accelerated approval by the U.S. FDA, Lurbinectedin is currently available to patients in Australia and Singapore via its Special Access Scheme. Lurbinectedin has also been granted Orphan Drug Designation in the U.S., the European Union, Switzerland and Australia for the treatment of patients with SCLC.
Luye Pharma Group's partner PharmaMar announced that the U.S. Food and Drug Administration (FDA) has approved Lurbinectedin for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression, after platinum-based chemotherapy. Lurbinectedin was approved under “Accelerated Approval” based on Overall Response Rate (ORR) and Duration of Response (DoR). Luye Pharma is working together with PharmaMar to develop the drug in China.
The FDA approval of Lurbinectedin is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with relapsed SCLC. The data showed that in relapsed SCLC, Lurbinectedin demonstrated an ORR of 35 percent and a median DoR of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC).
Of all types of lung cancer, SCLC is more invasive, progresses faster and metastasizes earlier, accounting for approximately 15% of all lung cancer incidences. There are very limited treatment options available for SCLC patients with disease progression after receiving platinum-based chemotherapy. According to the World Health Organization, the number of new lung cancer cases and deaths from lung cancer in China was about 774,000, and 690,000 in 2018 respectively.
Lurbinectedin is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, Lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
In April 2019, Luye Pharma and PharmaMar entered into a license development and commercialization agreement with respect to Lurbinectedin. Pursuant to the terms of the Agreement, Luye Pharma will have the exclusive rights to develop and commercialize Lurbinectedin for Small Cell Lung Cancer and all other indications in China. In addition, Luye Pharma will have the right to request the transfer of the technology for the manufacture of Lurbinectedin in China.
In addition to receiving the accelerated approval by the U.S. FDA, Lurbinectedin is currently available to patients in Australia and Singapore via its Special Access Scheme. Lurbinectedin has also been granted Orphan Drug Designation in the U.S., the European Union, Switzerland and Australia for the treatment of patients with SCLC.
