Luye Pharma Group announced today that the clinical trials application for Lurbinectedin, an innovative anticancer drug licensed-in from Pharma Mar, S.A. (PharmaMar), has been approved by the Center for Drug Evaluation of China, for the treatment of Small Cell Lung Cancer (SCLC).
Lurbinectedin is an inhibitor of RNA polymerase II and 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. The drug was approved according to the U.S. Food and Drug Administration’s (FDA) “Accelerated Approval” process in June (Brand Name: Zepzelca™), for the treatment of adult patients with metastatic SCLC with disease progression, after platinum-based chemotherapy.
In China and around the world, lung cancer is one of the most common cancers, with the highest rates of mortality. According to the World Health Organization, in 2018, the number of new lung cancer cases and deaths from lung cancer in China was around 774,000, and 690,000 respectively. SCLC is a relatively invasive, fast progressing and rapidly metastasizing cancer, accounting for approximately 15% of all lung cancer incidences. The development of new drugs for SCLC has been slow, and the number of effective drugs available in the market is limited.
The FDA approval for 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 Overall Response Rate (ORR) of 35% and a median Duration of Response (DoR) of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee).
To enable this innovative therapy to benefit Chinese patients as soon as possible, development of Lurbinectedin is also progressing rapidly in China. 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 has exclusive rights to the development and commercialization of Lurbinectedin for SCLC and all other indications in China. In addition, Luye Pharma also holds the right to request the transfer of technology for the manufacture of Zepzelca™ in China.
In addition to receiving approval from the FDA, Lurbinectedin is currently available to patients in Australia and Singapore via the Special Access Scheme. The New Drug Application (NDA) for Lurbinectedin has already been submitted in Switzerland, Canada and Israel. Lurbinectedin has also been granted an Orphan Drug Designation in the U.S., the European Union, Switzerland and Australia for the treatment of patients with SCLC.
Luye Pharma Group announced today that the clinical trials application for Lurbinectedin, an innovative anticancer drug licensed-in from Pharma Mar, S.A. (PharmaMar), has been approved by the Center for Drug Evaluation of China, for the treatment of Small Cell Lung Cancer (SCLC).
Lurbinectedin is an inhibitor of RNA polymerase II and 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. The drug was approved according to the U.S. Food and Drug Administration’s (FDA) “Accelerated Approval” process in June (Brand Name: Zepzelca™), for the treatment of adult patients with metastatic SCLC with disease progression, after platinum-based chemotherapy.
In China and around the world, lung cancer is one of the most common cancers, with the highest rates of mortality. According to the World Health Organization, in 2018, the number of new lung cancer cases and deaths from lung cancer in China was around 774,000, and 690,000 respectively. SCLC is a relatively invasive, fast progressing and rapidly metastasizing cancer, accounting for approximately 15% of all lung cancer incidences. The development of new drugs for SCLC has been slow, and the number of effective drugs available in the market is limited.
The FDA approval for 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 Overall Response Rate (ORR) of 35% and a median Duration of Response (DoR) of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee).
To enable this innovative therapy to benefit Chinese patients as soon as possible, development of Lurbinectedin is also progressing rapidly in China. 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 has exclusive rights to the development and commercialization of Lurbinectedin for SCLC and all other indications in China. In addition, Luye Pharma also holds the right to request the transfer of technology for the manufacture of Zepzelca™ in China.
In addition to receiving approval from the FDA, Lurbinectedin is currently available to patients in Australia and Singapore via the Special Access Scheme. The New Drug Application (NDA) for Lurbinectedin has already been submitted in Switzerland, Canada and Israel. Lurbinectedin has also been granted an Orphan Drug Designation in the U.S., the European Union, Switzerland and Australia for the treatment of patients with SCLC.
