Erlotinib is a drug used to treat certain types of non-small cell lung cancer. It is also used together with gemcitabine to treat pancreatic cancer and is being studied in the treatment of other types of cancer. Erlotinib is a type of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Also called CP-358,774, erlotinib hydrochloride, OSI-774, and Tarceva.
OSI Pharmaceuticals, Inc. announced today that its international partner for Tarceva® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease following four cycles of standard platinum-based first-line chemotherapy.
Pfizer Inc. announced today the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).
Idera Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2009.
Research published in the March issue of the Journal of Thoracic Oncology sought to determine whether differences existed in tolerance and efficacy between patients age 70 and over and younger patients with non-small cell lung cancer (NSCLC) receiving salvage targeted therapy with epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) or chemotherapy.
ArQule, Inc. today announced its financial results for the year and for the fourth quarter ended December 31, 2009.
Astellas Pharma Inc., a global pharmaceutical company, will commence a tender offer to acquire all outstanding shares of common stock of OSI Pharmaceuticals for $52.00 per share in cash, or an aggregate of approximately $3.5 billion on a fully diluted basis.
Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that Dr. Geoffrey I. Shapiro of Dana-Farber Cancer Institute, presented preclinical and clinical data on STA-9090, a potent second-generation Hsp90 inhibitor, at IASLC (International Association for the Study of Lung Cancer) 10th Annual Targeted Therapies of the Treatment of Lung Cancer Meeting in Santa Monica, CA.
Merrimack Pharmaceuticals, Inc. announced today that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with non-small cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121.
Synta Pharmaceuticals Corp. today announced that preclinical results presented at the “Bridging the Gap 2010” Hematologic Conference, held in Singapore City, Singapore, February 5-7, 2010, shows that STA-9090, a potent inhibitor of heat shock protein 90 (Hsp90), inhibits the Wilms’ tumor 1 (WT1) protein, a key transcription factor that drives disease progression in acute myeloid leukemia (AML) as well as certain other leukemias. STA-9090 is currently enrolling patients in two clinical trials in AML and other hematologic cancers.
OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days.
Epidermal growth factor receptor (EGFR) is a validated therapeutic target for non-small cell lung cancer. Researchers have now discovered a 93-gene signature that is associated with the presence of EGFR mutations in tumors from lung cancer patients and is a favorable prognostic marker in patients with early stage lung cancer.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that preclinical results presented at the AACR-IASLC (American Academy of Cancer Research – International Association for the Study of Lung Cancer) Joint Conference based on work done at Synta and at the Dana-Farber Cancer Institute in Boston showed that STA-9090, a potent, synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrated potent activity against 100% of all non-small cell lung cancer cell lines tested, including those with EGFR, HER2 or KRAS mutations including the EGFR T790 mutation that is present in roughly 50% of cases of erlotinib or gefitinib resistance.
Although erlotinib is an approved second-line therapy for lung cancer, its management is complicated by side effects that get worse as the dose increases.
OSI Pharmaceuticals, Inc. today announced that the U.S. Patent & Trademark Office (PTO) has granted reissue patent RE41,065, replacing Tarceva’s® (erlotinib) composition of matter patent (formerly No.5,747,498). The Company had applied for the reissue patent in February 2008, and on September 17, 2009 the Company had announced that the PTO had issued a “Notice of Allowance” accepting the Company’s application to correct certain errors relating to the claiming of compounds, other than Tarceva, which had fallen outside of the scope of the main claim of the patent.
Pfizer Inc. announced today the discontinuation of A4021016 (also known as ADVIGO 1016), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer (NSCLC) due to the study meeting predefined boundaries for early termination.
Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it is initiating a Phase 2 clinical study of STA-9090 in patients with advanced gastrointestinal stromal tumors (GIST). This is the sixth clinical study of STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor with a novel chemical structure.
Yesterday, an advisory committee to the Food and Drug Administration voted against the approval of Tarceva(R) (erlotinib) as maintenance treatment for advanced lung cancer patients.
Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it has initiated a Phase 2 clinical study of STA-9090 in non-small cell lung cancer (NSCLC).
OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending against approval of the daily pill Tarceva® (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or spread) following first-line treatment with platinum-based chemotherapy.
The National Comprehensive Cancer Network (NCCN) recently updated the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) to incorporate a new section about maintenance therapy, a number of new indications for specific therapies for advanced NSCLC, and the recently revised staging system for lung cancer.
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