Irinotecan hydrochloride is approved by the Food and Drug Administration (FDA) to be used with other drugs to treat colorectal cancer that has metastasized (spread to other parts of the body). It is also approved to treat metastatic colorectal cancer that has recurred (come back) or gotten worse after earlier chemotherapy. In addition to the uses that have been approved by the FDA, irinotecan hydrochloride is sometimes used to treat other types of cancer. Irinotecan hydrochloride is also being studied in the treatment of other types of cancer.
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has submitted an indication extension to the European Medicines Agency for the approval of Erbitux in combination with standard 1st line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer with high epidermal growth factor receptor expression.
APP Pharmaceuticals, Inc., announced today that it has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection, which is used for recurrent or progressive metastatic colorectal cancer.
Mersana Therapeutics today announced the initiation of a Phase 1b extension study with its lead cancer product, XMT-1001, a novel DNA topoisomerase I inhibitor based on the company's Fleximer® polymer conjugate platform, in second-line gastric cancer and second-/third-line non-small cell lung cancer. The study will be carried out in 10 clinical centers in the US.
Amgen has received notice that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Amgen's application to extend the marketing authorization in Europe for Vectibix® (panitumumab) to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).
Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC).
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced the companies have begun enrolling patients in a Phase 3 randomized, double-blind, placebo-controlled trial evaluating Nexavar tablets in combination with the oral chemotherapeutic agent, capecitabine, versus placebo plus capecitabine for the treatment of patients with advanced breast cancer.
PharmaEngine, Inc. announced today that two phase II studies of PEP02 (liposome irinotecan) in gastric and pancreatic cancer studies were presented at the 2011 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) in San Francisco, CA, USA.
Glioblastoma, the most common and lethal form of brain cancer and the disease that killed Massachusetts Senator Ted Kennedy, resists nearly all treatment efforts, even when attacked simultaneously on several fronts. One explanation can be found in the tumor cells' unexpected flexibility, discovered researchers at the Salk Institute for Biological Studies.
ArQule, Inc. today announced the presentation of Phase 1 results of a clinical trial among patients with metastatic colorectal cancer (CRC) treated with ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, in combination with irinotecan and cetuximab. ARQ 197 is under development by Daiichi Sankyo Co., Ltd. and ArQule.
YM BioSciences, a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development, today announced that results were reported from a randomized Phase II gastric cancer study of nimotuzumab being conducted by its licensees, Daiichi Sankyo Co., Ltd. in Japan and Kuhnil Pharma Co. Ltd., in Korea.
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.
Celator Pharmaceuticals today announced that it has agreed with Cephalon, Inc. to extend an existing research agreement into the next phase of development. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.
Oncolytics Biotech Inc. announced today that a U.S. Phase I study of REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022) is now open to enrollment. The principal investigator is Dr. Sanjay Goel of the Montefiore Medical Center at The Albert Einstein College of Medicine in New York.
Colorectal cancer (CRC) is the third most common cancer in men and women in the USA, with a new diagnosis made every 3.5 minutes and an associated death every 9 minutes.
Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.
Immunomedics, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that additional claims for the patent family, "RS7 antibodies," were issued as Patent No. 1,002,443 in Korea.
Oncothyreon Inc. today announced enrollment of the first patient in a Phase 1/2 trial of PX-866 in combination with the chimeric monoclonal antibody cetuximab (Erbitux®). PX-866 is a small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.
Celator Pharmaceuticals today announced the United States Patent and Trademark Office issued U.S Patent No. 7,850,990. This patent adds to the intellectual property surrounding Celator's innovative technology platforms and products.
Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene, a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that enrollment and treatment of patients in a Phase 1b clinical trial has been initiated to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer (CRC).
Enzon Pharmaceuticals, today announced the initiation of Phase I clinical studies, in collaboration with the National Cancer Institute, for two of the Company's novel oncology product candidates, EZN-2968 and EZN-2208 (PEG-SN38).