The report is divided into two broader sections (Ranking and Drug Profiles) and several sub-sections. We have sequenced 157 drugs into six segments based on total number of approvals: Segment A – 25+ approvals; Segment B – 15 to 24 approvals; Segment C – 10 to 14 approvals; Segment D – 5 to 9 approvals; Segment E – 2 to 4 approvals; Segment F – only one approval. Similarly, drugs are ranked in various segments based on unique approvals. Each drug in the drug profile section is described in the following three parts: Part 1 – basic information, Part 2 – approval timeline infographic and Part 3 – approval history tables.
Part 1: The basic information section covers:Trade names: Drugs are often known by different brand names (trade names) in different geographies. For instance, Rituxan is the trade name for Rituximab in the US, whereas it is known as Mabthera in Europe. We have presented each drug's trade name used in different geographies in our report.
Companies involved in marketing: Drugs are often sold or marketed in different geographies by different companies. For instance, Aranesp is marketed in the US and Europe by Amgen, whereas in Japan it is marketed by Kyowa Hakko Kirin.
Active pharmaceutical ingredient: Active pharmaceutical ingredients (API) are the active ingredients in medications, carried by the excipient. In each case, the drug has an API and it has a trade name, by which it is known in the market. For instance, Revlimid is the brand or trade name, whereas lenalidomide is its API.
Therapy segment: We have classified drugs into five major therapy segments ? Targeted, Chemo, Hormone, Vaccines and Adjuvants. For instance, Herceptin is a Targeted Therapy drug whereas Zytiga is a Hormone Therapy drug. Immuno-oncology: This is a growing area of cancer therapy. We have highlighted whether the drugs classified fall under this category or not. For instance, Opdivo is an immuno-oncology drug.Class of drug: Various therapy segments are further classified into classes of drugs. Monoclonal antibodies, tyrosine kinase and alkylating agent are examples of classes of drugs. Yervoy is a monoclonal antibody whereas Tarceva is a tyrosine kinase inhibitor.Designations: Drugs are given designations like "orphan", "priority review", "accelerated", etc., by regulatory authorities, which fast-track their approval process. For instance, Venclexta is an orphan drug (drug developed to treat a rare medical condition) and Erivedge is a "priority review" drug (drug granted expedited review by USFDA in case of treatment of neglected diseases).
First-in-class: In the drug snapshot section, we have mentioned whether a drug is first-in-class or not. Drugs that use a unique and new mechanism of action for treating a medical condition are known as first-in-class drugs. For instance, Avastin is a first-in-class drug as it was the first angiogenesis inhibitor.
Molecule type: Drugs are classified into two categories, small and large, on the basis of their molecular weight; greater than 900 daltons are large molecules and less than 900 daltons are small molecules. Large molecules are also known as biological drugs. Gazyva is a large molecule drug whereas Imbruvica is a small molecule drug.
Dosage form: We have explained whether the dosage is in the form of vials/injections (injectable) or tablets/capsules (oral). For instance, Tecentriq is an injectable drug whereas Thalomid is an oral tablet.
Route of administration: We have explained whether the drug is taken orally or through the intravenous route. For instance, Empliciti (for multiple myeloma) is taken through the intravenous route.
Black box warning: A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the USFDA when there is reasonable evidence of an association of a serious hazard with the drug. For instance, Tasigna (a drug for Chronic Myeloid Leukemia) comes with a black box warning "Tasigna has the propensity to elongate part of the heart's rhythm. This is generally not an issue. However, if the patient has a heart condition, or a family history of heart issues, he/she should discuss it with his/her doctor."
Mechanism of action: The term mechanism of action refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect. A mechanism of action usually includes mention of the specific molecular targets to which the drug binds, such as an enzyme or receptor.
First approved indication in the geographies US, EU and Japan: Many cancer drugs are often approved for more than one indication. We have highlighted the first approved indication of each drug in the various geographies. For instance, Xeloda was first approved for metastatic breast cancer in the US and Japan whereas, in Europe, it was first approved for colorectal cancer.
Note: In this report, we have covered only oncology indications and approvals. Any drug approved for a non-oncology indication in any geography but not approved for oncology indication is marked as "Not Applicable (not yet approved)". For instance, Vargatef is shown as "N/A (not yet approved)" in US (even though it is approved for a non-oncology indication Idiopathic Pulmonary Fibrosis under the trade name Ofev). Similarly, first approval dates mentioned in the table are also for oncology indications. For any drug that is first approved for a non-oncology indication and later for an oncology indication, we have considered the later date as the first approval date. For instance, for Aranesp, the first approval date is given as 2002 (when it was approved for an oncology indication chemotherapy-induced anaemia) despite the fact that it was approved first for a non-oncology indication anaemia from renal dialysis.
In case of trade names or brand names, we have used oncology brand names and excluded non-oncology brand names. Example: Afinitor is also known as Zortress in the US for treatment of a non-oncology indication, preventing transplant rejection. However, we have used Afinitor and not Zortress in this report. In some cases, brand names for oncology and non-oncology indications are the same. Example: Rituxan is used for oncology as well as rheumatoid arthritis.
Part 2: The approval timeline infographic
It is a graphical representation of approval history with date of approval, type of approval, indications, designations and lines of treatment.
Part 3: Approval history tables Drug approvals by USFDA, EMA and PMDA show detailed indications, broader indications, approval dates, in combination with, treatment preference and orphan designation dates. We have highlighted the unique indications in bold. Withdrawn and discontinued approvals are highlighted in red in the infographic and the tables. For all the drugs, we have excluded approvals related to non-oncology and benign tumor indications.
Rationale for ranking
We have ranked drugs based on total number of approvals and unique approvals. For example, if a particular drug is approved in the US, Europe and Japan for one indication, then its total number of approvals are three whereas its unique approval is one (as it is approved for totally one indication). Similarly, if a particular drug is approved for two same indications in the US and Japan and one indication (of those two) in Europe, then its total number of approvals are five whereas its unique approvals are two. The reasoning behind the total approval ranking is that each geography has separate filings, separate clinical trials and indicates separate incremental patient population, which gives separate incremental sales figures. The purpose of unique approval ranking, on the other hand, is to classify drugs based on unique number of indications approved.
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