Cancer Drugs in the FDA Fast Lane Drug Pipeline Update 2015
Jun 25, 2015, 08:36 ET
NEW YORK, June 25, 2015 /PRNewswire/ -- The US Food and Drug Administration (FDA) has throughout the last decades added four major ways it can speed up the market approval of new drugs, ranging from Fast track (1988), Accelerated approval (1992), Priority review (1992) to the most recent Breakthrough therapy (2012).
This pipeline update, Cancer Drugs in the FDA Fast Lane, gives a thorough account on which cancer drugs the FDA has chosen to favor for one or more of the above mentioned fast lane programs. Each drug carries in-depth information detailing overall developmental progression for each drug, targets, pathways, indications etc. helping you to analyze trends and facts on what could tip the FDA in your favor. Now be warned this is not really an exact science as Percy Ivy, associate chief of the Investigational Drug Branch at the US National Cancer Institute's Cancer Therapy Evaluation Program in Rockville, Maryland, expressed it by likens the definition of a breakthrough drug to US Supreme Court Justice Potter Stewart's notorious 1964 definition of pornography: "You're just going to know it when you see it," Ivy says.
There are today 133 companies plus partners developing 154 cancer drugs in the FDA fast lane drugs in 1382 developmental projects in cancer. In addition, there are 5 suspended drugs and the accumulated number of ceased drugs over the last years amount to another 57 drugs. Cancer Drugs In The Fda Fast Lane Drug Pipeline Update lists all drugs and gives you a progress analysis on each one of them. Identified drugs are linked to 166 different targets. All included targets have been cross-referenced for the presence of mutations associated with human cancer. To date 159 out of the 159 studied drug targets so far have been recorded with somatic mutations. The software application lets you narrow in on these mutations and links out to the mutational analysis for each of the drug targets for detailed information. All drugs targets are further categorized on in the software application by 50 classifications of molecular function and with pathway referrals to BioCarta, KEGG, NCI-Nature and NetPath.
How May Drug Pipeline Update Be of Use?
* Show investors/board/management that you are right on top of drug development progress in your therapeutic area. * Find competitors, collaborations partners, M&A candidates etc. * Jump start competitive drug intelligence operations * Excellent starting point for world wide benchmarking * Compare portfolio and therapy focus with your peers * Speed up pro-active in-/out licensing strategy work * Fast and easy way of tracking drugs using search engines; just one click from inside the application and you may search the World Wide Web and PubMed for any drug. Drug Pipeline Update is delivered to you as a downloadable application, which requires no installation on your computer. Please read more about application features and system requirements below.
Drug Pipeline Update at a Glance
Includes more than 133 principal companies plus their collaborators. There is direct access from inside the application to web pages of all principal companies.
Note: You are able to sort and find drugs according to companies and partners from drop-down menus in the application. You may also sort and find drugs according to country of companies.
Drug name & Synonyms
Lists commercial, generic and code names for drugs.
This Drug Pipeline Update contains 154 cancer drugs in the FDA fast lane drugs in development, which have a total of 1382 developmental projects in cancer. In addition there are suspended and ceased drugs.
Pipeline Breakdown According to Number of Drugs
Phase III# 84
Phase II# 123
Phase I# 85
No Data# 16
Note: You are able to sort and find drugs according to developmental stage from drop-down menu in the application.
Included cancer drugs in the FDA fast lane drugs are also in development for 271 other indications, where of 178 are different cancer indications.
Note: You are able to find and sort drugs according to type of indication from drop-down menu in the application.
All targets are cross-referenced with the Catalogue of Somatic Mutations in Cancer (COSMIC). It is designed to store and display somatic mutation information and related details and contains information relating to human cancers. To date 159 out of the 159 studied drug targets so far have been recorded with somatic mutations and the software application lets you narrow in on these mutations and links out to the mutational analysis for each of the drug targets for detailed information.
The identity of available biological structures on 132 drug targets was retrieved from the RCSB Protein Databank for you to easily review the 3356 structures available today among drug targets.
Identified drugs are linked to more than 166 different targets, divided into 50 classifications of molecular function:
- Acid phosphatase activity
- Auxiliary transport protein activity
- Carboxypeptidase activity
- Catalytic activity
- Cell adhesion molecule activity
- Chaperone activity
- Chemokine activity
- Cofactor binding
- Complement activity
- Cysteine-type peptidase activity
- Cytokine activity
- DNA topoisomerase activity
- DNA-directed DNA polymerase activity
- G-protein coupled receptor activity
- Glutathione transferase activity
- Growth factor activity
- Heat shock protein activity
- Hydrolase activity
- Isomerase activity
- Kinase activity
- Kinase regulator activity
- Ligand-dependent nuclear receptor activity
- Ligase activity
- Lipid kinase activity
- Lipid phosphatase activity
- Metallopeptidase activity
- MHC class I receptor activity
- Molecular function unknown
- Oxidoreductase activity
- Peptidase activity
- Peptide hormone
- Phosphorylase activity
- Protein binding
- Protein serine/threonine kinase activity
- Protein threonine/tyrosine kinase activity
- Protein-tyrosine kinase activity
- Receptor activity
- Receptor binding
- Receptor signaling complex scaffold activity
- Serine-type peptidase activity
- Structural constituent of cytoskeleton
- T cell receptor activity
- T cell receptor binding
- Transcription factor activity
- Transcription regulator activity
- Transferase activity
- Translation regulator activity
- Transmembrane receptor activity
- Transmembrane receptor protein tyrosine kinase activity
- Transporter activity
Identified targets are categorized into 18 different primary and alternate sub-cellular localizations:
- Cell surface
- Clathrin-coated vesicle
- Endoplasmic reticulum
- Golgi apparatus
- Plasma membrane
- Sarcoplasmic reticulum
- Secretory granule
Note: You are able to find and sort drugs according to target gene name, protein name, molecular function of target, target localization, presence of mutations and availability of biological structures of target from drop-down menus in the application.
Target Expression Profile
Direct links are provided from inside the application to 237 protein expression profiles of 149 drug targets in various human tissues and cancer types, cell lines and primary cells, including up to:
- 48 different normal tissue types
- 20 different types of cancer
- 47 cell lines
- 12 samples of primary blood cells
Identified targets have been cross referenced against their involvement in different cellular pathways, according to BioCarta, KEGG, NCI-Nature and NetPath.
- BioCarta# 210 Pathways
- KEGG# 172 Pathways
- NCI-Nature# 229 Pathways
- NetPath# 32 Pathways
Note: You are able to find and sort drugs according to targeted pathways from drop-down menus in the application.
In total there are different drug mechanism of action represented in this Drug Pipeline Update.
Note: You are able to find and sort drugs according to mechanism of action from drop-down menu in the application.
Identified drug compounds are described by:
Compound type, Chemical name, CAS Number and molecular weight
Note: You are able to sort and find drugs according to compound type from drop-down menu in the application.
Progress analysis and review of drug development. A typical drug profile reports on, depending on stage of development and available information:
Drug Name & Synonyms
Presentation of drug name and synonyms
Principal Company & Partners
Presentation of principal company and partners
Target and Molecular Function of Target
Described target(s) is/are presented with:
Official Gene Symbol – Chromosome Location – Gene & Protein Name – Molecular Function
Described target(s) is/are presented with primary and alternate localizations.
Target Expression Profiles
Links to protein expression profile(s) of target(s) in various human tissues, cell lines and primary cells, including up to:
48 different normal tissue types
20 different types of cancer
47 cell lines
12 samples of primary blood cells
All targets are cross-referenced with the Catalogue of Somatic Mutations in Cancer (COSMIC). It is designed to store and display somatic mutation information and related details and contains information relating to human cancers.
The identity of available biological structures on drug targets was retrieved from the RCSB Protein Databank for you to easily review what available structures of drug targets exist.
Described target(s) is/are matched for the involvement in cellular pathways according to BioCarta, KEGG, NCI-Nature and NetPath.
Drug mechanism of action
Summary field of developmental projects for the drug, including indication, developmental stage and status.
Cancer, myeloma – Phase II Clinical Trial – Active
Cancer, prostate – Phase III Clinical Trial – Ceased
Short introduction to drug
Compound type, Chemical name, CAS Number and molecular weight
Available patent information related to the drug is presented here.
Fillings and Approvals
Approvals and submissions
Deals & Licensing
Collaborations and deals
Availability for licensing
Phase IV Data
Available Phase IV development data, developmental history and scientific data.
Phase III Data
Available Phase III development data, developmental history and scientific data.
Phase II Data
Available Phase II development data, developmental history and scientific data.
Phase I Data
Available Phase I development data, developmental history and scientific data.
Phase 0 Data
Available Phase 0 development data, developmental history and scientific data.
Available preclinical development data, developmental history and scientific data.
Available discovery development data, developmental history and scientific data.
Search, Find and Filter Panel with Initial Result Presentation
With this panel you can define your selectivity in each drug search with up to 24 different drug specific parameters. Each parameter has multi-select options to them and can be used as either an inclusion parameter or exclusion parameter.
The initial result table is a dynamic sortable table which gives you a fast overview of found results and can be narrowed down further by your own additional keywords.
Direct linkage from inside the application to related internet resources
- Drug data is linked to search engines like Google and PubMed
- Drug target data is linked directly to BioCarta, Human Protein Atlas, KEGG, NCI-Nature, NetPath etc.
- Direct links to company web pages of companies
Dynamic Report Generator
Our dynamic report generator lets you with ease and speed generate html reports directly in your web browser (Internet Explorer and FireFox), whether it is a single drug profile or an entire search you want have a report of.
- Operating system: Windows (2000/XP/Vista/7/8) for Mac Users the service is only available online
- Browser Application (Internet Explorer, Firefox, Chrome, Safari)
- Internet access (to access related internet resources)
Read the full report: http://www.reportlinker.com/p01601227-summary/view-report.html
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