[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphomaData from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meetingBasel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates fo...
Source: Roche Investor Update - April 15, 2024 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphomaData from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meetingBasel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates fo...
Source: Roche Media News - April 15, 2024 Category: Pharmaceuticals Source Type: news

Oxaliplatin in Older Adults With Resected Colorectal Cancer? Oxaliplatin in Older Adults With Resected Colorectal Cancer?
Dr David Kerr discusses the use of adjuvant chemotherapy with oxaliplatin to high-risk patients with resected colorectal cancer.Medscape Oncology (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 23, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Commentary Source Type: news

FDA Approves Onivyde Combination for Metastatic Pancreatic Cancer
THURSDAY, Feb. 15, 2024 -- The U.S. Food and Drug Administration has approved Onivyde (irinotecan liposome injection) plus oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line treatment for adults living with metastatic pancreatic... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 15, 2024 Category: Pharmaceuticals Source Type: news

Frontline Irinotecan Liposome OKed in Mets Pancreatic Cancer Frontline Irinotecan Liposome OKed in Mets Pancreatic Cancer
The approval was based on improved overall and PFS with irinotecan liposome alongside oxaliplatin, fluorouracil, and leucovorin vs gemcitabine plus nab-paclitaxel.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 14, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New First-Line Option for Pancreatic Cancer Approved
(MedPage Today) -- The FDA approved irinotecan liposome (Onivyde) in combination with oxaliplatin, leucovorin, and fluorouracil (NALIRIFOX) for the first-line treatment of metastatic pancreatic adenocarcinoma, the agency announced on Tuesday.... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - February 13, 2024 Category: American Health Source Type: news

Sequential Therapy Boosts Survival in Metastatic Pancreatic Cancer
(MedPage Today) -- For patients with metastatic pancreatic ductal adenocarcinoma (PDAC), sequential treatment with nab-paclitaxel (Abraxane) plus gemcitabine followed by modified oxaliplatin, leucovorin, and fluorouracil (mFOLFOX) led to improved... (Source: MedPage Today Gastroenterology)
Source: MedPage Today Gastroenterology - January 31, 2024 Category: Gastroenterology Source Type: news

European Commission approves Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphomaApproval is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is given for a fixed period of time and made to be readily available, providing patients with a treatment end date and treatment-free periodBasel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) ha...
Source: Roche Media News - July 11, 2023 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphomaApproval is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is given for a fixed period of time and made to be readily available, providing patients with a treatment end date and treatment-free periodBasel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) ha...
Source: Roche Investor Update - July 11, 2023 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate and a median duration of response of 1.5 years (18.4 months)1Given over a fixed period of time,Columvi provides patients with a treatment end date and potential time off treatmentColumvi is part of Roche ' s industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approvedLunsumioto treat follicular lymphomaBasel, 16 June 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved ...
Source: Roche Media News - June 27, 2023 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate and a median duration of response of 1.5 years (18.4 months)1Given over a fixed period of time,Columvi provides patients with a treatment end date and potential time off treatmentColumvi is part of Roche ' s industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approvedLunsumioto treat follicular lymphomaBasel, 16 June 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved ...
Source: Roche Investor Update - June 16, 2023 Category: Pharmaceuticals Source Type: news

ASCO: FOLFOX Noninferior to Chemoradiotherapy for Overall Survival in Rectal Cancer
FRIDAY, June 9, 2023 -- Neoadjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) is noninferior to preoperative chemoradiotherapy with respect to overall survival for patients with locally advanced rectal cancer who are... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 9, 2023 Category: Pharmaceuticals Source Type: news

Falls during oxaliplatin-based chemotherapy for gastrointestinal malignancies - (lessons learned from) a prospective study - Galliardt M, Betz U, Birklein F, Drees P, Geber C.
This prospective cohort study aimed to characterise the impact of oxaliplatin-based chemotherapy and its neurotoxic side effects (i.e., chemotherapy-induced neuropathy) on functional fall-risk and falls. Twenty chemotherapy-na ïve participants (mean age, 5... (Source: SafetyLit)
Source: SafetyLit - June 5, 2023 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

CHMP recommends EU approval of Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Once approved,Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphomaThe recommendation is based on results from the phase I/II NP30179 study, whereColumvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is part of Roche ’s industry-leading CD20xCD3 T-cell-engaging bispecific developmentprogramme, which aims to transform the treatment experience for people with blood cancers using off-the-shelf and fixed-duration optionsBasel, 26 ...
Source: Roche Investor Update - April 26, 2023 Category: Pharmaceuticals Source Type: news