Addition of 3 indications for TREAKISYM® and approval in Japan
First written in FY2016-Q2. 9 of 21 entries say "Advanced", first in FY2016. Latest entry: FY2021-Q2.
No other company in this theme has enough history to compare yet.
- FY2021-Q2RestatedAnnual report
「Following the indications for which approval had already been obtained, the Phase III clinical trial of BR therapy for r/r DLBCL was subject to a partial-change application for marketing approval in May 2020, and approval was obtained in March 2021.」
The status of approval obtained in March 2021 for BR therapy for r/r DLBCL continues to be disclosed. - FY2021-Q1RestatedAnnual report
「On 23 March 2021, we obtained partial-change approval for the marketing approval of TREAKISYM® lyophilized powder for injection for combination therapy with bendamustine and rituximab (BR therapy) and combination therapy with bendamustine, rituximab, and polatuzumab vedotin (P-BR therapy) for relapsed or refractory diffuse large B-cell lymphoma (hereinafter, “r/r DLBCL”). BR therapy became available for immediate use, while P-BR therapy will become available once polatuzumab vedotin is listed in the National Health Insurance drug price list.」
The conditions for using BR therapy and P-BR therapy for r/r DLBCL following partial-change approval in March 2021 continue to be disclosed. - FY2020AchievedAnnual report
「For the Phase III clinical trial of BR therapy for relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), the company filed a partial change application for the marketing authorization items in May 2020 based on favorable results in which the response rate, the trial’s primary endpoint, exceeded the expected response rate, and obtained approval in March 2021.」
For the fourth indication, r/r DLBCL, approval was obtained in March 2021 following the partial change application. - FY2020-Q3AdvancedAnnual report
「Evaluating survival data, including overall survival and progression-free survival, from combination treatment with TREAKISYM® and rituximab is important data for defining the role of this drug in DLBCL treatment. Accordingly, a follow-up study using overall survival as the primary endpoint is under way.」
A follow-up study with overall survival as the primary endpoint was under way in addition to the partial-change application for the additional r/r DLBCL indication. - FY2020-Q2AdvancedAnnual report
「For the Phase III clinical trial of BR therapy for the fourth indication, relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), following the approved indications, we filed a partial-change application for marketing approval in May 2020 based on favorable results in which the response rate, the primary endpoint, exceeded the expected response rate. In addition, following Chugai Pharmaceutical Co.,Ltd.’s filing in June 2020 of a marketing application for polatuzumab vedotin in combination with BR therapy for r/r DLBCL, we filed a partial-change application in July 2020 for marketing approval of combination therapy with TREAKISYM®, polatuzumab vedotin, and rituximab.」
In addition to the May 2020 partial-change application for the fourth r/r DLBCL indication, a July 2020 partial-change application was filed for combination therapy with polatuzumab vedotin and other agents. - FY2020-Q1AdvancedAnnual report
「For the Phase III clinical trial of BR therapy for the fourth indication, relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), the company announced in November 2019 that the response rate, the trial’s primary endpoint, had exceeded the expected response rate, producing favorable results, and filed a partial change application for approval of the marketing authorization items in May 2020.」
For the fourth r/r DLBCL indication, the company filed a partial change application in May 2020 after disclosing favorable Phase III results. - FY2019RestatedAnnual report
「For the Phase III clinical trial of BR therapy for the fourth indication, relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), following the approved indications, we announced in November 2019 that favorable results had been obtained, with the response rate, the primary endpoint, exceeding the expected response rate. We are currently preparing to file the marketing application in the second quarter of 2020.」
The explanation that favorable Phase III results exceeded the expected response rate and that preparations were under way for a second-quarter 2020 application continued without substantive change from the previous quarter. - FY2019-Q3AdvancedAnnual report
「We completed patient enrollment in April 2019, and in September 2019 completed the observation period for all subjects (LPLV: Last Patient Last Visit). Favorable results were obtained for the primary endpoint, response rate, exceeding the expected response rate. We will continue preparations toward the marketing application planned for the second quarter of 2020.」
The observation period for all subjects in the Phase III r/r DLBCL trial was completed, with results exceeding the expected response rate. A marketing application was planned for the second quarter of 2020. - FY2019-Q2RestatedAnnual report
「Because there was no effective standard therapy for this indication, there was an urgent medical need, and patient groups and relevant academic societies had submitted strong requests to the regulatory authorities for BR therapy to be made available. To provide a new treatment option, we began a Phase III clinical trial in August 2017, steadily advanced patient enrollment following the first patient registration in January 2018, and completed enrollment in April 2019. After the follow-up period for enrolled patients ends, we will continue preparations toward filing the marketing application.」
For the fourth r/r DLBCL indication, preparations for the marketing application continued after completion of enrollment in April 2019, pending completion of follow-up. - FY2019-Q1AdvancedAnnual report
「We began the Phase III clinical trial in August 2017, steadily progressed patient enrollment following the enrollment of the first patient in January 2018, and completed patient enrollment in April 2019. We will prepare diligently for the marketing application after the follow-up period for enrolled patients has ended.」
For the fourth relapsed or refractory DLBCL indication, the company completed patient enrollment in the Phase III trial and moved to preparing the marketing application after follow-up. - FY2018RestatedAnnual report
「In addition to the 3 indications for which approval has already been obtained, we began a Phase III clinical trial for the fourth indication, relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and are working diligently to enroll patients toward obtaining approval.」
The Phase III trial and patient enrollment for DLBCL continued, and no new approval was disclosed. - FY2018-Q3RestatedAnnual report
「In addition to the 3 indications for which approval has already been obtained, we began a Phase III clinical trial for the fourth indication, relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and are working diligently to enroll patients toward obtaining approval.」
The Phase III trial and patient enrollment continued for the fourth DLBCL indication. No new approval was disclosed in this filing. - FY2018-Q2RestatedAnnual report
「In addition to the 3 indications for which approval has already been obtained, we began a Phase III clinical trial for the fourth indication, relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and are working diligently to enroll patients toward obtaining approval.」
The Phase III trial and patient enrollment continued for the fourth DLBCL indication in addition to the 3 approved indications. - FY2018-Q1RestatedAnnual report
「In addition to the 3 indications for which approval has already been obtained, we began a Phase III clinical trial for the fourth indication, relapsed or refractory intermediate- or high-grade non-Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL)), and are working diligently to enroll patients toward obtaining approval.」
For the fourth indication, the Phase III trial began and patient enrollment continued after completion of first-patient enrollment in January 2018. - FY2017AdvancedAnnual report
「For this indication, we completed a Phase II clinical trial and, in response to the high medical need, began a Phase III clinical trial in August 2017 aimed at adding the indication following consultations with the Pharmaceuticals and Medical Devices Agency. We completed enrollment of the first patient in January 2018.」
For TREAKISYM®’s fourth indication, the first patient was enrolled in January 2018 following the start of the Phase III trial. Approval had not yet been obtained. - FY2017-Q3AdvancedAnnual report
「For the fourth indication, relapsed or refractory intermediate- to high-grade non-Hodgkin lymphoma (diffuse large B-cell lymphoma), we began a Phase III clinical trial in August 2017 following consultations with PMDA.」
Following consultations with PMDA, the company began the Phase III clinical trial for the fourth indication in August 2017. Approval had not yet been obtained. - FY2017-Q2AdvancedAnnual report
「In addition to the 3 indications for which approval has already been obtained, we continue to work toward obtaining a fourth indication to maximize the product’s value and provide new treatment options for patients in need. For relapsed or refractory intermediate- or high-grade non-Hodgkin lymphoma (diffuse large B-cell lymphoma), for which a Phase II clinical trial has already been completed, preparations are under way for a Phase III clinical trial aimed at adding the indication following consultations with the Pharmaceuticals and Medical Devices Agency in response to the high medical need.」
For the fourth indication, the company progressed to preparing a Phase III clinical trial following consultations with PMDA. - FY2017-Q1RestatedAnnual report
「In addition to the 3 indications described above for which approval has already been obtained, we are continuing to pursue a fourth indication to maximize the product’s value for patients who need new treatment options. For relapsed or refractory aggressive or highly aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma), for which a Phase II clinical trial has already been completed, we are currently consulting with the Pharmaceuticals and Medical Devices Agency in response to the high unmet medical need and continuing to consider adding the indication.」
Three of the 4 indications have been approved, while consultations with PMDA and consideration of the fourth indication continue. No new approval was disclosed in this filing. - FY2016AdvancedAnnual report
「For this product, we are working to obtain 4 indications in order to serve patients who need new treatment options and maximize the product’s value, and have already obtained approval for 3 of them.」
The number of approved indications increased from 2 in the previous disclosure to 3 of the 4 targeted indications. The company continued to consider adding the remaining indication for relapsed or refractory aggressive or highly aggressive non-Hodgkin lymphoma. - FY2016-Q3RaisedAnnual report
「For this product, we are working to add 4 indications in order to serve patients who need new treatment options and maximize TREAKISYM’s business value, and have already obtained approval for 2 of them.」
The target was expanded from 3 additional indications to 4. The disclosure also reports that approval has already been obtained for 2 of the 4 indications. - FY2016-Q2First statedAnnual report
「For this product, we are working to add 3 indications in order to serve patients who need new treatment options and maximize the product’s value.」
The company set a goal of adding 3 indications and proceeded with specific approval-related steps, including domestic applications, consultations with PMDA and expert discussions. It also disclosed that Astellas Pharma Inc. withdrew its European marketing application.