Merrimack Reports Ipsen Announcement of Approval By The US FDA of Onivyde® (Irinotecan Liposome Injection) Plus 5 Fluorouracil/Leucovorin and Oxaliplatin (NALIRIFOX) as a First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
The FDA on Wednesday approved Taiho Oncology’s Lonsurf (trifluridine and tipiracil) with bevacizumab for metastatic colorectal cancer (mCRC) in those who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
Lower rates of diarrhea and overall bowel dysfunction were reported with the use of neoadjuvant fluorouracil and oxaliplatin (FOLFOX) vs neoadjuvant pelvic chemoradiation with fluorouracil (5FCURT) in patients with locally advanced rectal cancer, according to patient-reported outcomes (PROs) from the phase 2/3 PROSPECT trial (NCT01515787). However, lower rates of other toxicities were reported in patients treated with 5FUCRT.1
SHANGHAI, May 5, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced that AB011 in combination with atezolizumab monoclonal antibody, Roche's PD-L1 checkpoint inhibitor, along with chemotherapy (capecitabine and oxaliplatin) achieved IND clearance from the CDE for first-line treatment Claudin18.2 (CLDN18.2) positive unresectable locally advanced, recurrent or metastatic gastric cancer/gastroesophageal junction cancer.
Seagen Announces FDA Accelerated Approval of TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
TOKYO, December 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in combination with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin). Zolbetuximab is an investigational first-in-class Claudin-18.2 (CLDN18.2) targeted monoclonal antibody, for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
VANCOUVER, British Columbia--(BUSINESS WIRE)--Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that new clinical data for zanidatamab, a HER2?targeted bispecific antibody, demonstrate promising response rates and durability in first-line HER2-positive GEA. These data were presented today by lead study investigator, Geoffrey Ku, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), at the ESMO Annual Congress.
Among patients with stage III colon cancer, comparison of patients aged >70 with those <70 years showed that elderly patients tolerated adjuvant oxaliplatin/flouropyrimidines therapy less well and had poorer relapse-free interval (RFI) rates, according to findings from a large subgroup analysis of the phase III TOSCA presented at the ESMO Virtual Congress 2020 by Sara Lonardi of the IRCCS Istituto Oncologico Veneto in Padova, Italy (lead author Gerardo Rosati of the Azienda Ospedaliera Regionale S. Carlo di Potenza, Potenza, Italy).
LONG BEACH, Calif., May 29, 2020 /PRNewswire/ -- Investigators at MedStar Washington Hospital Center and Nagourney Cancer Institute report the results of a study that examined the impact of prior FOLFOX chemotherapy exposure on Oxaliplatin resistance as a potentially important contributing factor for the PRODIGE 7 clinical trial's failure to improve progression free or overall survival in colon cancer patients who received post-operative HIPEC. The PRODIGE 7 study reported in 2018 is a multi-center, phase III trial that randomized 265 colon cancer patients to observation or HIPEC following six cycles of systemic chemotherapy.
The latest move comes following the completion of Japan’s Pharmaceutical and Medical Devices Agency (PMDA) review of the company’s clinical trial notification (CTN), which is equivalent to a US investigational new drug application (IND).