ONO PHARMACEUTICAL CO., LTD. (PRINCETON, NJ, March 30, 2016) - Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Medicines Agency (EMA) validated a type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.
Bristol-Myers Squibb (BMS) has a robust clinical development program in Opdivo monotherapy and in combination therapy with other therapeutic drugs in a variety of tumor types overseas, including Head and Neck Cancer, Glioblastoma, Small Cell Lung Cancer, Urothelial Cancer, Hepatocellular Carcinoma, Esophageal Cancer, Hodgkin Lymphoma, Colorectal Cancer, Solid Tumors (Triple-Negative Breast Cancer, Gastric Cancer, Pancreatic Cancer), Blood Cancer, etc. In Japan, Ono Pharmaceutical Co., Ltd. (ONO) launched Opdivo for the treatment of unresectable melanoma in September 2014. ONO received an approval for additional indication of unresectable, advanced or recurrent non-small cell lung cancer in December 2015. In addition, ONO has submitted supplemental applications for additional indications of Renal Cell Cancer and Hodgkin Lymphoma, and is conducting clinical development program including Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Glioblastoma, Ovarian Cancer, Urothelial Cancer, Biliary Tract Cancer, etc.
In Japan, ONO and BMS (and BMS Japan subsidiary BMSKK) have formed a strategic partnership that includes co-development, co-commercialization, and co-promotion of multiple immunotherapies for patients with cancer.
Attached from the following page is the press release made by BMS for your information. Contact
ONO PHARMACEUTICAL CO., LTD.
Corporate Communications public_relations@ono.co.jp
Opdivo® (nivolumab) for the Treatment of Classical Hodgkin Lymphoma Patients
(PRINCETON, NJ, March 30, 2016) - Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Medicines Agency (EMA) validated a type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.
"We are eager to continue to extend the use of Opdivo as a treatment option and potentially provide hematology with its first PD-1 inhibitor, a type of treatment that is designed to work with the PD-1 pathway and leverage the immune system to help fight classical Hodgkin lymphoma," said Jean Viallet, M.D., Oncology Global Clinical Research Lead, Bristol-Myers Squibb. "We are hopeful to build on expanding our hematology franchise and bring the science of Immuno-Oncology to these adult relapsed and refractory classical Hodgkin lymphoma patients in Europe who often have limited remaining treatment options."
CheckMate -205 is a Phase 2 study evaluating the safety and efficacy of Opdivo in patients with relapsed or refractory cHL. The results of this trial are expected to be presented at a medical meeting later this year.
About Hodgkin Lymphoma
Hodgkin lymphoma, which also is known as Hodgkin disease, is one of two main types of lymphoma, a group of cancers most often beginning in the lymph nodes. Hodgkin lymphoma is characterized by malignant lymphocytes called Reed-Sternberg cells. The other type of lymphoma is non-Hodgkin lymphoma, which is much more common. In the European Union,
about 12,200 new cases and 2,600 deaths are expected each year. There remains a significant unmet need for patients who have relapsed or have become refractory to current treatments.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation and chemotherapy for certain types of cancer.
We have a comprehensive clinical portfolio of investigational and approved Immuno- Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for important measures. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents, and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO, and LAG-3. These
pathways may lead to potential new treatment options - in combination or monotherapy - to help patients fight different types of cancers.
Our collaboration with academia, as well as small and large biotech companies, is responsible for researching the potential Immuno-Oncology and non-Immuno-Oncology combinations, with the goal of providing new treatment options in clinical practice.
At Bristol-Myers Squibb, we are committed to conducting research for hard-to-treat cancers.
About Opdivo
Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. It blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway's suppressive signaling on the immune system, including the interference with an anti-tumor immune response.
Opdivo's broad global development program is based on Bristol-Myers Squibb's understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching the potential of Immuno-Oncology in hard-to-treat cancers. This scientific expertise serves as the basis for the Opdivo development program, which includes a broad range of Phase 3 clinical trials. To date, the Opdivo clinical development program has enrolled more than 18,000 patients.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 and currently has regulatory approval in 48 countries, including the United States, Japan and in the European Union.
INDICATIONS
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
ONO Pharmaceutical Co. Ltd. issued this content on 01 April 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 01 April 2016 07:03:06 UTC
Original Document: http://www.ono.co.jp/eng/news/pdf/sm_cn160401.pdf
