Expansion of Opdivo’s indications and progress in international development and sales
First written in FY2016. 36 of 37 entries say "Advanced", first in FY2017-Q1. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「In January this year in Taiwan and in February this year in South Korea, we obtained approval for the combination therapy of Opdivo and Yervoy for unresectable, advanced or recurrent colorectal cancer with high microsatellite instability (MSI-High) or deficient mismatch repair (dMMR).」
For the Opdivo-Yervoy combination therapy, approvals were obtained in Taiwan and South Korea for MSI-High or dMMR colorectal cancer, indicating progress in international indication expansion. - FY2026-H1AdvancedAnnual report
「In June this year, approval was obtained in Japan for the combination therapy of Opdivo and Yervoy for the indication of unresectable hepatocellular carcinoma. In July this year, approval was obtained in South Korea and Taiwan for the combination therapy of Opdivo and Yervoy for the indication of hepatocellular carcinoma that was unresectable or metastatic. In August this year, approval was obtained in Japan for the combination therapy of Opdivo and Yervoy for the indication of unresectable, advanced or recurrent colorectal cancer with high microsatellite instability (MSI-High).」
For the Opdivo-Yervoy combination therapy, approvals were obtained for hepatocellular carcinoma in Japan, South Korea and Taiwan and for MSI-High colorectal cancer in Japan, indicating progress in indication expansion in Japan and overseas. - FY2025AdvancedAnnual report
「In July last year, Opdivo received approval in South Korea for the indication of unresectable or metastatic urothelial carcinoma in combination with chemotherapy in the first-line setting. In October last year, Opdivo received approval in Taiwan for the same indication. In December last year, Opdivo received approval in Japan for the indication of unresectable urothelial carcinoma in combination with chemotherapy in the first-line setting.」
Approvals were obtained in South Korea, Taiwan and Japan for Opdivo as first-line treatment for urothelial carcinoma, indicating progress in indication expansion and sales rollout in Japan and overseas. - FY2025-H1AdvancedAnnual report
「In August this year, an application was submitted in Japan for the combination therapy of Opdivo and Yervoy for the indication of unresectable hepatocellular carcinoma. In July this year, Opdivo received approval in South Korea for the indication of unresectable or metastatic urothelial carcinoma in combination with chemotherapy in the first-line setting. In October this year, Opdivo received approval in Taiwan for the indication of unresectable or metastatic urothelial carcinoma in combination with chemotherapy in the first-line setting.」
The application in Japan for the Opdivo-Yervoy combination therapy for hepatocellular carcinoma and approvals in South Korea and Taiwan for urothelial carcinoma indicate progress in indication and combination-therapy development in Japan and overseas. - FY2024-Q3AdvancedAnnual report
「Note 1: Approval was obtained in Japan for Opdivo for the indication of malignant mesothelioma, excluding malignant pleural mesothelioma.」
Opdivo received approval in Japan for malignant mesothelioma, indicating progress in indication expansion. - FY2024-Q2AdvancedAnnual report
「In August this year, development of Opdivo for prostate cancer in Japan, South Korea and Taiwan was discontinued because efficacy could not be confirmed. In August this year, a Phase II trial of the combination therapy of Opdivo and the prostaglandin receptor antagonist ONO-4578 for gastric cancer was started in Japan, and in October this year, corresponding trials were started in South Korea and Taiwan.」
While development for prostate cancer was discontinued, Phase II trials of the ONO-4578 combination therapy for gastric cancer were started in Japan, South Korea and Taiwan, indicating progress in Opdivo's indication and combination-therapy development. - FY2024-Q1AdvancedAnnual report
「※1: An application was submitted in Japan for Opdivo for the indication of epithelial skin malignancies. ※2: Applications were submitted in Japan for Braftovi capsules and Mektovi tablets for the indication of unresectable thyroid cancer with a BRAF mutation treated with the two-drug combination therapy.」
Applications were submitted in Japan for Opdivo for epithelial skin malignancies and for the Braftovi-Mektovi combination therapy for thyroid cancer, indicating progress in development toward indication expansion. - FY2023AdvancedAnnual report
「Approval was obtained in Japan, South Korea and Taiwan for the combination therapy of Opdivo and chemotherapy for the indication of neoadjuvant therapy for resectable non-small cell lung cancer.」
The combination therapy of Opdivo and chemotherapy advanced to approval for neoadjuvant therapy for non-small cell lung cancer in Japan, South Korea and Taiwan. The document also describes the discontinuation of development of adjuvant therapy for gastric cancer and certain solid tumors. - FY2023-Q2AdvancedAnnual report
「In May this year, approval was obtained in Japan for combination therapy with Yervoy and combination therapy with chemotherapy for the indication of unresectable, advanced or recurrent esophageal cancer. In July this year, approval was obtained in Taiwan for combination therapy with Yervoy and combination therapy with chemotherapy for the indication of advanced or metastatic esophageal squamous cell carcinoma. In April this year, approval was obtained in Taiwan for the indication of adjuvant therapy in patients with muscle-invasive urothelial carcinoma at high risk of recurrence following complete resection.」
For Opdivo-related combination therapies, approvals for esophageal cancer were obtained in Japan and Taiwan, and approval was also obtained in Taiwan for adjuvant therapy for urothelial carcinoma, indicating progress in indication expansion in Japan and overseas. - FY2023-Q1AdvancedAnnual report
「Changes from the results announcement for the fiscal year ended March 2022 Note 1: Approval was obtained in Japan and Taiwan for the combination of Opdivo and Yervoy and the combination of Opdivo and chemotherapy for the indication of curatively unresectable, advanced or recurrent esophageal cancer.」
For Opdivo-related combination therapies, approvals for esophageal cancer were obtained in Japan and Taiwan, marking progress toward indication expansion and sales in Japan and overseas. - FY2022AdvancedAnnual report
「In November last year, approval was obtained in Japan for combination therapy with chemotherapy for the indication of unresectable, advanced or recurrent gastric cancer. In March this year, approval was obtained in Japan for the indication of adjuvant therapy in patients with urothelial carcinoma. In April this year, approval was obtained in Taiwan for the indication of adjuvant therapy in patients with muscle-invasive urothelial carcinoma at high risk of recurrence following complete resection.」
For Opdivo, approvals in Japan and overseas for gastric cancer, urothelial carcinoma and other indications are progressing, with continued expansion of cancer types and lines of therapy. - FY2022-Q3AdvancedAnnual report
「Note 1: Approval was obtained in Japan for Opdivo for the indication of cancer of unknown primary. Note 2: Approval was obtained in Korea for the BTK inhibitor Belexibr tablets for the indication of relapsed or refractory primary central nervous system lymphoma of B-cell origin.」
An additional domestic approval for Opdivo and approval in South Korea for Braftovi capsules were obtained, indicating progress in indication expansion and sales rollout in Japan and overseas. - FY2022-Q2AdvancedAnnual report
「In May this year, approval was obtained in Japan for the combination therapy with Yervoy for the indication of unresectable, advanced or recurrent malignant pleural mesothelioma. In June this year, approval was obtained in South Korea for the combination therapy with Yervoy for the indication of unresectable malignant pleural mesothelioma. In September this year, approval was obtained in Taiwan for the combination therapy with Yervoy for the indication of unresectable malignant pleural mesothelioma. In August this year, approval was obtained in Japan for the combination therapy with Cabometyx tablets for the indication of unresectable or metastatic renal cell carcinoma.」
Approvals for Opdivo combination therapies progressed in Japan, South Korea and Taiwan, marking concrete advances in indication and combination-therapy development in Japan and overseas. - FY2022-Q1AdvancedAnnual report
「※1: Approval was obtained in Japan and South Korea for the combination therapy of Opdivo and Yervoy for the indication of unresectable, advanced or recurrent malignant pleural mesothelioma. / ※2: An application was submitted in Japan for Opdivo for the indication of cancer of unknown primary. / ※3: An application was submitted in Japan for Opdivo for an additional pediatric dosage and administration for Hodgkin lymphoma.」
For Opdivo, approvals were obtained in Japan and South Korea for combination therapies, and applications were submitted in Japan for cancer of unknown primary and pediatric Hodgkin lymphoma, making indication expansion more concrete. - FY2021AdvancedAnnual report
「In September last year, approval was obtained in Japan for the combination therapy with Yervoy for the indication of colorectal cancer with high microsatellite instability (MSI-High) that was unresectable, advanced or recurrent and had progressed following chemotherapy. In November last year, approval was obtained in Japan for non-small cell lung cancer involving combination therapy with platinum-containing chemotherapy, combination therapy with Yervoy and other therapies. In March this year, an application was submitted in Japan for the indication of adjuvant therapy for urothelial carcinoma.」
For Opdivo, approvals were obtained for colorectal cancer and non-small cell lung cancer, and applications were submitted for urothelial carcinoma and other indications, expanding indication and combination-therapy development in Japan and overseas. - FY2021-Q3AdvancedAnnual report
「※1: Approval was obtained in Japan and South Korea for the combination therapy of Opdivo and Yervoy for the indication of unresectable, advanced or recurrent non-small cell lung cancer. / ※4: Opdivo started a Phase II trial for biliary tract cancer in Japan, South Korea and Taiwan.」
The document describes approval in Japan and South Korea for Opdivo-related non-small cell lung cancer therapies and the start of Phase II trials for biliary tract cancer in Japan, South Korea and Taiwan, indicating progress in indication and combination-therapy development in Japan and overseas. - FY2021-Q2AdvancedAnnual report
「In April this year, approval was obtained in South Korea for the indication of unresectable, advanced or recurrent esophageal squamous cell carcinoma that was refractory or intolerant to chemotherapy containing a fluoropyrimidine and a platinum agent. In June this year, approval was obtained in Taiwan for the indication of unresectable, advanced or recurrent esophageal squamous cell carcinoma that had progressed following combination therapy containing a fluoropyrimidine and a platinum agent. In September this year, approval was obtained in Japan for the combination therapy with Yervoy for the indication of colorectal cancer with high microsatellite instability (MSI-High) that was unresectable, advanced or recurrent and had progressed following chemotherapy. In October this year, an application was submitted in Japan for the combination therapy with cabozantinib malate, the kinase inhibitor Cabometyx tablets/cabozantinib malate being developed by Takeda Pharmaceutical Company Limited, for the indication of renal cell carcinoma that was unresectable or metastatic.」
For Opdivo, approvals for esophageal cancer in South Korea and Taiwan, approval in Japan for colorectal cancer in combination with Yervoy, and an application in Japan for renal cell carcinoma in combination with cabozantinib are progressing, expanding indication and combination-therapy development in Japan and overseas. - FY2021-Q1AdvancedAnnual report
「※1: Opdivo received approval in Taiwan for the indication of unresectable, advanced or recurrent esophageal squamous cell carcinoma that had progressed following combination therapy containing a fluoropyrimidine and a platinum agent. / ※2: Opdivo started a Phase III trial for prostate cancer in Japan, South Korea and Taiwan.」
Opdivo received an additional approval for esophageal squamous cell carcinoma in Taiwan and started a Phase III trial for prostate cancer in Japan, South Korea and Taiwan, indicating progress in its international indication expansion and development. - FY2020AdvancedAnnual report
「In May this year, approval was obtained in Taiwan for adjuvant therapy in patients with melanoma with lymph node metastasis following complete resection or metastatic melanoma. In May this year, approval was obtained in Taiwan for Opdivo monotherapy or combination therapy with Yervoy for the indication of metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR). In April this year, approval was obtained in South Korea for the indication of unresectable, advanced or recurrent esophageal squamous cell carcinoma that was refractory or intolerant to chemotherapy containing a fluoropyrimidine and a platinum agent.」
Multiple additional approvals were obtained in Taiwan and South Korea, indicating progress in Opdivo's international indication expansion and sales rollout. - FY2020-Q3AdvancedAnnual report
「※5: Opdivo started a Phase II trial for biliary tract cancer.」
Opdivo started a Phase II trial for biliary tract cancer, indicating progress in development toward indication expansion. - FY2020-Q2AdvancedAnnual report
「In May this year, approval was obtained in Taiwan for adjuvant therapy in patients with melanoma with lymph node metastasis following complete resection or metastatic melanoma. In July this year, a Phase III trial was started in Japan for the combination therapy with Yervoy in metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR). In September this year, a Phase III trial was started in Japan, South Korea and Taiwan for the combination therapy with Yervoy in hepatocellular carcinoma.」
An additional approval in Taiwan, the start of a Phase III trial for colorectal cancer in Japan, and the start of Phase III trials for hepatocellular carcinoma in Japan, South Korea and Taiwan indicate progress in Opdivo's indication and combination-therapy development in Japan and overseas. - FY2020-Q1AdvancedAnnual report
「Opdivo received approval in Taiwan for the indication of metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR) that had progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. / The combination therapy of Opdivo and Yervoy received approval in Taiwan for the indication of metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR) that had progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.」
In Taiwan, approvals were obtained for Opdivo monotherapy and the combination therapy with Yervoy for colorectal cancer, indicating progress in international indication expansion. - FY2019AdvancedAnnual report
「In January this year, approval was obtained in Taiwan to add the indication of non-small cell lung cancer with a history of chemotherapy with a platinum agent. In August last year, approval was obtained in Japan for the combination therapy with the antineoplastic agent Yervoy for the indication of unresectable or metastatic renal cell carcinoma. In January this year, a Phase III trial was started in Japan for bladder cancer involving combination therapy with the IDO1 inhibitor ONO-7701.」
The document describes an additional approval for Opdivo in Taiwan, approval in Japan for the Yervoy combination therapy, and the start in Japan of a Phase III trial combining Opdivo with an IDO1 inhibitor, indicating progress in indication and combination-therapy development in Japan and overseas. - FY2019-Q3AdvancedAnnual report
「Note 5: The company obtained approval in Taiwan for a partial change to the import marketing authorization for the combination of Opdivo and Yervoy for the indication of previously untreated intermediate- and poor-risk advanced renal cell carcinoma.」
An additional approval was obtained in Taiwan for the renal cell carcinoma indication of the Opdivo-Yervoy combination therapy, marking concrete progress in international development and sales. - FY2019-Q2AdvancedAnnual report
「In August this year, Opdivo received approval for partial changes to its marketing approval for the indications of unresectable, advanced or recurrent malignant pleural mesothelioma that had progressed following chemotherapy and adjuvant therapy for melanoma. In June this year, Bristol-Myers Squibb received import and marketing approval in China for Opdivo for the indication of locally advanced or metastatic non-small cell lung cancer following platinum-containing chemotherapy. In August this year, Bristol-Myers Squibb received approval in the United States for partial changes to Opdivo's marketing approval for the indication of metastatic small cell lung cancer that had progressed following chemotherapy with a platinum agent and at least 1 prior treatment.」
In addition to additional indications for malignant pleural mesothelioma and melanoma in Japan, approvals were obtained in China, the United States and elsewhere, indicating progress in Opdivo's indication expansion and international development and sales. - FY2019-Q1AdvancedAnnual report
「Changes since the results announcement for the fiscal year ended March 2018 ※4: Opdivo started a Phase III trial for ovarian cancer in Europe and the United States. ※5: Opdivo started a Phase II trial for pancreatic cancer in Europe and the United States.」
For Opdivo, Phase III and Phase II trials for ovarian cancer and pancreatic cancer, respectively, were started in Europe and the United States, indicating progress in international development and indication expansion. - FY2018AdvancedAnnual report
「In January this year, Opdivo received approval in Taiwan for partial changes to its import and marketing approval for the indication of advanced or recurrent gastric cancer or gastroesophageal junction cancer following 2 or more chemotherapy regimens. In April this year, Bristol-Myers Squibb received approval in the United States for partial changes to the marketing approval for the combination of Opdivo and Yervoy for the indication of previously untreated intermediate- and high-risk advanced renal cell carcinoma.」
Additional indications and applications in Taiwan, South Korea, the United States and Europe, as well as development of combination therapies, are progressing, indicating advances in Opdivo's international development and sales. - FY2018-Q3AdvancedAnnual report
「Opdivo received approval for a partial change to its import marketing authorization for the indication of advanced or recurrent gastric cancer or gastroesophageal junction cancer after 2 or more lines of chemotherapy.」
An additional approval for gastric cancer and gastroesophageal junction cancer was obtained in Taiwan, indicating progress in Opdivo's international indication expansion. - FY2018-Q2AdvancedAnnual report
「In September this year, Opdivo received approval for partial changes to its marketing approval for the indication of unresectable, advanced or recurrent gastric cancer that had progressed following chemotherapy. In August this year, Bristol-Myers Squibb received approval in the United States for partial changes to Opdivo's marketing approval for the indication of metastatic colorectal cancer that had progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan and was MSI-H or dMMR. In October this year, Bristol-Myers Squibb announced that the FDA had accepted its application for partial changes to Opdivo's marketing approval for the indication of melanoma at high risk of recurrence following complete resection.」
Additional approvals were obtained for gastric cancer in Japan and metastatic colorectal cancer in the United States, and an additional application for melanoma was accepted, indicating progress in indication expansion in Japan and overseas. - FY2018-Q1AdvancedAnnual report
「Opdivo submitted an application in the United States for partial changes to its marketing approval for the indication of previously treated hepatocellular carcinoma. / Opdivo started a Phase II trial in multiple myeloma.」
Opdivo's international development and indication expansion are progressing through the application for an additional hepatocellular carcinoma indication in the United States and the start of a Phase II trial in multiple myeloma. - FY2017AdvancedAnnual report
「In March this year, Opdivo received approval for partial changes to its marketing approval for the indication of recurrent or metastatic head and neck cancer. In April this year, Opdivo was designated in Japan as a product eligible for the Sakigake designation system established by the Ministry of Health, Labour and Welfare for biliary tract cancer.」
The document describes progress in indication expansion and development, including additional approval for head and neck cancer in Japan and Sakigake designation for biliary tract cancer. - FY2017-Q3AdvancedAnnual report
「Opdivo intravenous infusion received approval in Japan for partial changes to its marketing approval for the indication of relapsed or refractory classical Hodgkin lymphoma. / Opdivo intravenous infusion submitted an application in Japan for partial changes to its marketing approval for the indication of unresectable, advanced or recurrent gastric cancer. / Opdivo intravenous infusion started a Phase III trial in ovarian cancer.」
With approval in Japan for classical Hodgkin lymphoma, an application for approval for gastric cancer, and the start of a Phase III trial in ovarian cancer, Opdivo's indication expansion and development are progressing. - FY2017-Q2AdvancedAnnual report
「In August this year, Opdivo received approval for partial changes to its marketing approval in Japan for the indication of unresectable or metastatic renal cell carcinoma. In September this year, Bristol-Myers Squibb started a Phase III trial of Opdivo in combination with Yervoy for malignant pleural mesothelioma. In October this year, Bristol-Myers Squibb announced that the FDA had accepted its application for partial changes to Opdivo's marketing approval for the indication of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma whose disease had progressed during or following platinum-containing therapy.」
The document describes the additional approval of a renal cell carcinoma indication in Japan, the start of a Phase III trial of a combination therapy overseas, and acceptance of an application for partial changes to the approval for urothelial carcinoma, indicating progress in indication expansion and international development. - FY2017-Q1AdvancedAnnual report
「Opdivo intravenous infusion has started a Phase III trial in multiple myeloma. / Opdivo intravenous infusion has started a Phase III trial in gastroesophageal junction cancer and esophageal cancer. / In Japan, Opdivo intravenous infusion submitted an application for partial changes to the marketing approval for the indications of recurrent or metastatic head and neck cancer.」
The document describes applications for additional indications in Japan, Taiwan, Europe and the United States, U.S. approval for Hodgkin lymphoma, and the start of Phase III trials in multiple cancer types, indicating progress in indication expansion and international development. - FY2016First statedAnnual report
「Opdivo obtained approval for a partial change to its marketing authorization for the indication of unresectable, advanced or recurrent non-small cell lung cancer. In May of the previous year, in South Korea, the company began marketing Opdivo directly for malignant melanoma.」
The document describes expanded indications through additional domestic approvals, the start of in-house sales in South Korea, and trials and approvals across multiple regions by overseas partners.