A free glossary of oncology-related terms and resource organizations.
Why use a resource like nm|OK?
Unlike reports that are 'dead on arrival' nm|OK is a constantly updated comprehensive report on every aspect of oncology drug development. click
Drugs profiled in nm|OK
nm|OK profiles over 4,310 drugs/in vivo imaging agents in development:
3,653 anticancer agents addressing over 100 cancer types and thousands of clinical indications. Of these, 1,695 are in active development; 821 have been or are currently being evaluated in clinical trials and 539 of these are targeted agents.
757 drugs for the management of complications of cancer and its treatment (pain, infection, mucositis, emesis, etc.)
nm|OK also profiles over 552 marketed drugs (anticancer agents=335, adjuncts=197) globally, providing trial results from monotherapy and combination therapy trials.
In vitro testing (IVT) products
nm|OK profiles over 200 companies and hundreds of products (screening tests, diagnostics, pharmacogenomics, prognostics, disease monitoring tests, theragnostics, etc.) in the in vitro testing area in oncology.
Enabling technologies/drug delivery
nm|OK describes hundreds of technology platforms used to discover, evaluate, optimize, and or deliver anticancer agents such as cytotoxics, synthetic nucleic acid sequences, small molecule drugs, monoclonal antibodies, fusion proteins, etc.
Targets in oncology
nm|OK describes over 1,000 molecular moieties that may be target candidates of anticancer strategies or used as in vitro testing markers.
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The headlines below refer to selected records among the hundreds updated in nm|OK within a 30-day period. A summary of the updated information, the complete records for each item on the list, and numerous other updated entries are available to subscribers upon logging in. Samples of records from each module are here.
Special reports are reviews of current developments of oncology and related drugs by indication, mechanism, delivery technology, etc. as well as personalized medicine, including biomarkers, diagnostics, theragnostics, prognostics, pharmacogenomics, disease monitoring tests, etc. Samples of special reports are here.
eIF5A1, eIF-5A, factor 5A1 (F5A1), factor 5A, SNS01, SNS-01, SNS01-T
Fedratinib TG101348, TG-101348, SAR302503
Pacritinib SB1518, ONX0803
Xofigo (previously Alpharadin)
Laboratory Corporation of America
Bromodomain-containing 4 (BRD4)
EU Funded Consortium to Develop an Actively Personalized Vaccine (APVAC) for the Treatment of Glioblastoma
In November 2013, immatics Biotechnologies and the newly EU-funded Glioma Actively Personalized Vaccine Consortium (GAPVAC; http://gapvac.eu) selected the HLA-A*02-restricted peptides and completed GMP manufacturing, which is a prerequisite for the GAPVAC clinical trial. Patients enrolling in this trial will be vaccinated with two personalized vaccines, APVAC 1 composed of off-the-shelf pre-manufactured peptides binding to different human leukocyte antigen (HLA) receptors highly overexpressed in a patient's tumor and APVAC 2 consisting of de novo manufactured peptides from tumor-specific mutations. (more...)
Yale-Novogen Venture to Develop Treatment for Ovarian Cancer by Targeting Cancer Stem Cells
In November 2013, Novogen and Yale University formed CanTx, a joint venture (JV) that combines research advances by Gil Mor, MD, PhD, Professor of Obstetrics, Gynecology, and Reproductive Sciences at Yale University who was the first to isolate and clone ovarian cancer stem cells, with Novogen's expertise in anticancer drug development. The JV is headquartered in New Haven and early R&D operations will take place in Dr. Mor's lab under the Novogen's Sponsored Research Agreement with the university. Novogen owns 85% of CanTx, which is headed by Graham Kelly, PhD, the CEO of Novogen. The arrangement was facilitated by the Yale Office of Cooperative Research. The focus of CanTx is to target ovarian cancer stem cells. (more...)
FDA Approves Gazyva (Obinutuzumab or GA101) in Combination With Chlorambucil for the Treatment of Patients with Previously Untreated (First Line) Chronic Lymphocytic Leukemia (CLL)
In November 2013, the FDA approved Gazyva (obinutuzumab or GA101) in combination with oral chlorambucil chemotherapy for the treatment of patients with previously untreated (first line) chronic lymphocytic leukemia (CLL). Gazyva is the first drug approved under the FDA's Breakthrough Therapy designation and the fifth Roche oncology drug to be approved by the FDA in the past 3 years.
Approval is based on PFS results from the pivotal multicenter, open label, randomized, 3-arm phase III clinical trial (protocol ID: BO21004, 2009-012476-28; CLL1; NCT01010061), conducted in cooperation with the German CLL Study Group (GCLLSG), investigating the efficacy and safety profile of either Gazyva plus chlorambucil or MabThera/Rituxan plus chlorambucil compared to chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions. (more...)
Priority Review Granted to the BLA Seeking FDA Approval for Ramucirumab Monotherapy in Gastric Cancer in the Second Line Setting
In October 2013, the FDA granted Priority Review to the regulatory submission for Lilly’s anticancer drug ramucirumab (IMC-1121B) as monotherapy for advanced gastric cancer following disease progression after initial chemotherapy. If approved, ramucirumab will be the first FDA-approved therapy for patients in this setting. Stomach cancer is the second leading cause of cancer death globally. It is anticipated that the FDA will act on this application in the second quarter of 2014. This BLA for ramucirumab was based on data from REGARD, a global, randomized, double blind phase III clinical trial that evaluated ramucirumab plus best supportive care (BSC) compared to placebo plus BSC as a treatment in patients with advanced gastric cancer, including adenocarcinoma of the gastro-esophageal junction, following progression after initial chemotherapy. A registration dossier is also under regulatory review by the European Medicines Agency (EMA) for a Marketing Authorization Application (MAA). (more...)
The Incredible Complexity of Drug Development and Personalized Medicine in Oncology-Triple Negative Breast Cancer (TNBC)
Triple negative breast cancer (TNBC) is only one of the hundreds of distinct types of cancer. It accounts for about 15% to 25% of all cases of breast cancer. TNBC, characterized by a lack of expression of the hormone receptors for estrogen and progesterone and HEr2, is an aggressive form of breast cancer with no effective treatment options. The severity of the disease and the commercial opportunity for an effective treatment that rivals the $1.5 billion market for Herceptin in triple positive breast cancer, has intensified research in this area. Most novel agents in TNBC are in early clinical development with no standouts having emerged to date. (more...)
FDA Approves Roche's Perjeta in the Neoadjuvant Setting in Patients With HEr2-positive Breast Cancer
In September 2013, the FDA granted accelerated approval to Roche's Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel for the treatment of patients with high risk, HEr2-positive early stage breast cancer in the neoadjuvant setting. This approval is based primarily on data from a phase II clinical trial in which a pathologic complete response (pCR) was noted in nearly 40% of patients treated with this combination. The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data. A full review of data from the ongoing phase III APHINITY clinical trial (protocol ID: BO25126; 2010-022902-41; BIG 04-11; TOC4939G; NCT01358877) will be required for the accelerated approval to be converted to a full approval. APHINITY compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for the adjuvant treatment of patients with HEr2-positive early stage breast cancer. (more...)
Inhibition of the Vascular Endothelial Growth Factor (VEGF) Pathway for the Treatment of Cancer
The success of Avastin, an antiangiogenesis agent targeting the VEGF pathway, has prompted the development of numerous similarly acting agents. Avastin, with global revenues of $6,210.5 million in fiscal 2010, is the most commercially successful anticancer drug ever to reach the market. Future Oncology has published a review of VEGF inhibition in the treatment of cancer. (more...)
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