BEIJING, China & CAMBRIDGE, MA, USA I November 19, 2020 I BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has approved XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM). Developed by Amgen and licensed to BeiGene in China under a strategic collaboration commenced earlier this year, XGEVA is also approved and marketed in China for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.
“We began commercializing XGEVA in China in July of this year and are excited to offer it for prevention of skeletal-related events, which can be caused by bone metastases from solid tumors and MM and can include pathologic fractures, spinal cord compression, as well as the need for surgery or radiation to the bone,” said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “This approval provides us with an opportunity to offer these patients in China a new medicine to help prevent SREs and is an important addition to our expanding oncology product portfolio.”
The approval of XGEVA for the prevention of SREs in patients with bone metastasis from solid tumors and MM was based on clinical results from four randomized international trials that enrolled over 7,000 patients (NCT00321464, NCT00330759, NCT00321620, and NCT01345019). In each trial, the main outcome measure was demonstration of noninferiority of time to first SRE as compared to the standard of care zoledronic acid. Supportive secondary outcome measures included superiority of time to first SRE and time to first and subsequent SRE, respectively. XGEVA significantly delayed the time to first SRE compared to zoledronic acid in patients with bone metastases from breast cancer, castration-resistant prostate cancer (CRPC), as well as from other solid tumors including non-small cell lung cancer (pre-specified integrated analysis; p < 0.0001). In patients with lytic lesions due to MM, XGEVA was noninferior to zoledronic acid in delaying the time to first SRE.
The most common adverse reactions in patients receiving XGEVA with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia. For multiple myeloma patients receiving XGEVA, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation of XGEVA was osteonecrosis of the jaw. All adverse reactions seen in the clinical trials were similar for both XGEVA and zoledronic acid.
“Amgen is accelerating our oncology pipeline for patients in China with difficult-to-treat cancers through our collaboration with BeiGene,” said My Linh Kha, Vice President & General Manager, Amgen Japan Asia-Pacific (JAPAC). “We congratulate our teams and celebrate the approval of this new indication of XGEVA for the prevention of skeletal-related events. With the approval of XGEVA in this new indication, we are excited about the positive health impact it may have for patients in China.”
About Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors and in Patients with Multiple Myeloma
Bone metastasis occurs when cancer cells break away from the original tumor and spread to the bones, where they begin to multiply.i Bone is the third most frequent site of metastasis, following lung and liver.ii While nearly all types of cancer can spread or metastasize to the bones, prostate and breast cancer are responsible for the majority of metastases, up to 70 percent.iii Osteolytic lesion is a type of bone metastases characterized by destruction of normal bone, which is present in more than 90 percent of patients with multiple myeloma during the course of the disease.iv
About XGEVA® (denosumab)
XGEVA targets the RANKL pathway to prevent the formation, function and survival of osteoclasts, which break down bone. XGEVA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA is also indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
U.S. Approved Indications
XGEVA® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
XGEVA® is indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
XGEVA® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 4,700+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
ihttps://www.mayoclinic.org/diseases-conditions/bone-metastasis/symptoms-causes/syc-20370191
ii Coleman R. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 2001;27:165-76.
iii Cecchini M, Wetterwald A, Pluijm G, Thalmann G. Molecular and biological mechanisms of bone metastasis. EAU Update Series 2005;3:214-26
iv International Myeloma Working Group. International Myeloma Working Group (IMWG) Criteria for the Diagnosis of Multiple Myeloma. http://imwg.myeloma.org/international-myeloma-working-group-imwg-criteria-for-the-diagnosis-of-multiple-myeloma/.
SOURCE: BeiGene
Post Views: 22
BEIJING, China & CAMBRIDGE, MA, USA I November 19, 2020 I BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has approved XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM). Developed by Amgen and licensed to BeiGene in China under a strategic collaboration commenced earlier this year, XGEVA is also approved and marketed in China for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.
“We began commercializing XGEVA in China in July of this year and are excited to offer it for prevention of skeletal-related events, which can be caused by bone metastases from solid tumors and MM and can include pathologic fractures, spinal cord compression, as well as the need for surgery or radiation to the bone,” said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “This approval provides us with an opportunity to offer these patients in China a new medicine to help prevent SREs and is an important addition to our expanding oncology product portfolio.”
The approval of XGEVA for the prevention of SREs in patients with bone metastasis from solid tumors and MM was based on clinical results from four randomized international trials that enrolled over 7,000 patients (NCT00321464, NCT00330759, NCT00321620, and NCT01345019). In each trial, the main outcome measure was demonstration of noninferiority of time to first SRE as compared to the standard of care zoledronic acid. Supportive secondary outcome measures included superiority of time to first SRE and time to first and subsequent SRE, respectively. XGEVA significantly delayed the time to first SRE compared to zoledronic acid in patients with bone metastases from breast cancer, castration-resistant prostate cancer (CRPC), as well as from other solid tumors including non-small cell lung cancer (pre-specified integrated analysis; p < 0.0001). In patients with lytic lesions due to MM, XGEVA was noninferior to zoledronic acid in delaying the time to first SRE.
The most common adverse reactions in patients receiving XGEVA with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia. For multiple myeloma patients receiving XGEVA, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation of XGEVA was osteonecrosis of the jaw. All adverse reactions seen in the clinical trials were similar for both XGEVA and zoledronic acid.
“Amgen is accelerating our oncology pipeline for patients in China with difficult-to-treat cancers through our collaboration with BeiGene,” said My Linh Kha, Vice President & General Manager, Amgen Japan Asia-Pacific (JAPAC). “We congratulate our teams and celebrate the approval of this new indication of XGEVA for the prevention of skeletal-related events. With the approval of XGEVA in this new indication, we are excited about the positive health impact it may have for patients in China.”
About Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors and in Patients with Multiple Myeloma
Bone metastasis occurs when cancer cells break away from the original tumor and spread to the bones, where they begin to multiply.i Bone is the third most frequent site of metastasis, following lung and liver.ii While nearly all types of cancer can spread or metastasize to the bones, prostate and breast cancer are responsible for the majority of metastases, up to 70 percent.iii Osteolytic lesion is a type of bone metastases characterized by destruction of normal bone, which is present in more than 90 percent of patients with multiple myeloma during the course of the disease.iv
About XGEVA® (denosumab)
XGEVA targets the RANKL pathway to prevent the formation, function and survival of osteoclasts, which break down bone. XGEVA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA is also indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
U.S. Approved Indications
XGEVA® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
XGEVA® is indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
XGEVA® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 4,700+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
ihttps://www.mayoclinic.org/diseases-conditions/bone-metastasis/symptoms-causes/syc-20370191
ii Coleman R. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 2001;27:165-76.
iii Cecchini M, Wetterwald A, Pluijm G, Thalmann G. Molecular and biological mechanisms of bone metastasis. EAU Update Series 2005;3:214-26
iv International Myeloma Working Group. International Myeloma Working Group (IMWG) Criteria for the Diagnosis of Multiple Myeloma. http://imwg.myeloma.org/international-myeloma-working-group-imwg-criteria-for-the-diagnosis-of-multiple-myeloma/.
SOURCE: BeiGene
Post Views: 22
