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.
Telotristat etiprate LX1032, LX1606
Pelareorep Reolysin, Reovirus type 3 Dearing (RT3D)
Rilimogene galvacirepvec/rilimogene glafolivec
MUC1 dendritic cell vaccine, CVac, mannan-MUC1 fusion protein (M-FP)
Alvocidib, flavopiridol NSC-649890, L86-8275, HMR-1275, HMR1275
Cobimetinib XL518, XL-518, GDC-0973
Motesanib diphosphate AMG706, AMG-706
Entrectinib RXDX-101, NMS-E628
Valeant Pharmaceuticals International
Critical Outcome Technologies
MicroRNA 34a (MIR34A)
England's National Cancer Drugs Fund Removes 25 Cancer Indications Involving 16 Separate Drugs from its FY16 Covered List
In January 2015, the CDF removed 25 cancer treatment indications involving 16 separate agents from its annual funding list beginning on March 15, 2015. The fund exceeded its budget by ~ £100 million in FY15. This decision eliminates ~ £80 million ($121.3 million) from the FY16 budget for these indications which is nevertheless increased to £340 million in FY16, with its mandate ending on March 15, 2016. In addition the CDF rejected outright another 33 indications involving 19 separate approved anticancer agents. The CDF covered list now includes 62 approved indications. The most telling aspect of the removals is the incredible variety of highly specific indications, some approved and others off label, associated with these drugs that illustrate the complexity of this disease. In addition to the basic cancer type, the clinical indications specify disease stage, biomarker expression, line of treatment often specifying previous exposure by agent, performance status, distinct agent combinations, etc. Each of these specific indications has been evaluated in clinical trials providing the regulators with base line information as to their cost effectiveness. (more...)
FDA Approves Avastin in Combination with Chemotherapy for the Treatment of Platinum-resistant Ovarian Cancer in the Third Line Setting
In November 2014, the FDA approved Avastin in combination with chemotherapy with paclitaxel, pegylated liposomal doxorubicin or topotecan, for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, previously treated with no more than two chemotherapy regimens. In August 2014, Avastin was approved in the EU for this indication. Approval was based on results from AURELIA, a phase III clinical trial (protocol ID: MO22224; 2009-011400-33; NCT00976911), in which participants were randomized to one of six treatment arms (paclitaxel, topotecan or pegylated liposomal doxorubicin with or without Avastin). The primary endpoint of the trial was investigator-assessed PFS. (more...)
Neratinib Reduces CNS Metastases in Patients With HEr2-positive Locally Recurrent or Metastatic Breast Cancer
In November 2014, top line results were presented from the multicenter, international (n=33), randomized, 2-arm, NEfERTT phase II clinical trial (protocol ID: 3144A2-3005; NEFERTT; NCT00915018) with PB272 (neratinib) plus paclitaxel versus trastuzumab (Herceptin) plus paclitaxel for the treatment of patients withHEr2-positive locally recurrent or metastatic breast cancer in the first line setting. The trial enrolled 479 patients. As expected, there was no statistically significant difference in PFS and ORR between the paclitaxel plus neratinib arm compared to the paclitaxel plus trastuzumab arm but there was a significant decrease in the incidence of CNS metastases in the neratinib arm compared to the trastuzumab arm. This represents the first randomized trial with a HEr2 targeted agent that statistically significantly reduced the incidence of CNS metastases, which may provide a meaningful point of differentiation for neratinib in the treatment of HEr2 positive breast cancer. While other HEr2 targeted drugs provide a clinically meaningful benefit to patients with HEr2 positive breast cancer, these drugs have had little impact on CNS metastases. There is an unmet clinical need for reducing the incidence of CNS metastases which may be filled with neratinib. (more...)
Speeding the Time it Takes to Evaluate Novel Anticancer Treatments: the I-SPY-2 Adaptive Clinical Trial
Clinical evaluation of novel anticancer agents/treatments routinely takes over 10 years and costs nearly $1 billion. Currently, numerous agents are in development for even longer lengths of time. This situation prompted the rethinking of how to evaluate the results of clinical trials in real time rather than wait until the trial’s conclusion. In this approach, referred to as adoptive design, the effectiveness of a treatment addressing a narrow clinical indication selected on validated science, is evaluated in a small patient population in real time using statistical techniques (Barker AD, etal, Clin Pharmacol Ther, Jul 2009;86(1):97-100) based on a Bayesian model to identify regimens with ≥85% predictive probability of success. In this manner, a decision can be quickly arrived at as to the treatment’s effectiveness. The first attempt to employ this approach is represented by the I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2), a phase II clinical trial (protocol ID: 097517; NCT01042379) in women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (http://www.ispy2.org). In this trial, various agents are used to treat a small number of patients with several types of breast cancer in the adjuvant setting to determine which are most effective in which patient based on disease characteristics and biomarker expression. The trial’s primary endpoint is pathologic complete response (pCR). The trial employs a rigorous patient profile based on the biology of each participant’s tumor and the outcome of each participant who completes treatment is used to decide treatment for women who subsequently join the trial. Drugs that provide a benefit are then entered into late stage evaluation.
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...)
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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