Understanding Drug Approval and Researching Newly Approved Cancer Treatments
This fact sheet provides patient-focused information about the FDA drug approval process and guidance on researching FDA-approved agents for patients with cancer.
The US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research is responsible for approving over-the-counter (OTC) and prescription drugs in the United States based on their safety and effectiveness.1 Sponsors must submit an application that provides details about the drug, including data supporting its safety and efficacy. In addition, the FDA has developed and currently uses 4 different approaches to expedite drug approvals, with the goal of providing an approval decision as quickly as possible: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review.2
Fast Track and Accelerated Approval are designed to expedite the review of drugs that fulfill an unmet need for serious conditions. Accelerated Approval allows the use of a surrogate endpoint to demonstrate efficacy.2 Breakthrough Therapy applies to drugs that may improve outcomes over available therapies, and Priority Review indicates that the FDA intends to act on an application within 6 months.
The FDA typically announces new drug approval through FDA news releases and adds approved drugs to their publicly available database, Drugs@FDA.3 Many manufacturers will also announce approval of their drug by press release. Therefore, FDA-approved drugs can also be searched by using a search engine such as Google and search terms such as “[cancer type] AND FDA approved.” The year can be added to narrow a search to more recently approved drugs. The FDA and other institutions, however, provide searchable databases that provide an easier and somewhat more reliable strategy to find FDA-approved drugs with more targeted search results.
Searching for Approved Drugs
The following list offers examples of websites that maintain databases of FDA-approved drugs, some of which also provide an app with similar functions as the website.
Drugs@FDA enables search by drug name, active ingredient, or application number.3 A return provides information such as dosage strength, formulation, marketing status (i.e., prescription or OTC), date of approval, any letters, reviews, labels, and package inserts. The FDA also lists new additions or deletion for prescription and OTC drugs by year.4 The FDA also has an app, Drugs@FDA Express, available for Android and Apple, that can be used to search approved drugs.5 An email subscription service that provides FDA updates is also offered.6
CenterWatch is a website that provides information to providers and patients about clinical trials and new drug approvals. For drug approvals, CenterWatch lists drugs approved by year, specialty, condition, manufacturer, and name.7
Drugs.com is a website that provides a variety of information and tools about drugs, including a pill identifier, interactions checker, prescribing information, and pricing. The site has an advanced search page where “new drug approvals” and “FDA drug alerts” can be selected.8 There is also a webpage for new drug approvals, FDA drug alerts, and FDA consumer updates. Drugs.com also offers an app, which is available for Android and Apple, that provides the same information in a mobile-friendly format.9
National Cancer Institute
The National Cancer Institute (NCI) provides a searchable list of FDA-approved drugs for cancer and conditions related to cancer.10 The NCI also maintains a blog that features articles about recent drug approvals including commentary about how the approval may affect patient care and/or future research.11
American Association for Cancer Research
The American Association for Cancer Research (AACR) provides a list of articles featuring FDA approvals for anticancer drugs at their Foundation's website.12
American Society of Clinical Oncology
The American Society of Clinical Oncology (ASCO) hosts a site called Oncology Practice Insider that allows users to search all FDA alerts, including new drug approvals.13
- U.S. Food and Drug Administration. How Drugs are Developed and Approved. Website. Updated October 4, 2018. www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/. Accessed November 12, 2018.
- U.S. Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. Website. Updated February 23, 2018. www.fda.gov/forpatients/approvals/fast/default.htm. Accessed November 12, 2018.
- U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Website. www.accessdata.fda.gov/scripts/cder/daf/. Accessed November 12, 2018.
- U.S. Food and Drug Administration. Additions/Deletions for Prescription and OTC Drug Product Lists. Website. www.fda.gov/drugs/informationondrugs/ucm086229.htm. Accessed November 12, 2018.
- U.S. Food and Drug Administration. Tools To Keep You Informed. Website. Updated September 4, 2018. www.fda.gov/drugs/ucm136245.htm. Accessed November 12, 2018.
- U.S. Food and Drug Administration. Subscription Management Center. Website. http://go.fda.gov/subscriptionmanagement. Accessed November 12, 2018.
- CenterWatch. 2018 FDA Approved Drugs. Website. www.centerwatch.com/drug-information/fda-approved-drugs/. Accessed November 12, 2018.
- Drugs.com. Advanced Search. Website. www.drugs.com/search_advanced.html. Accessed November 12, 2018.
- Drugs.com. Drugs.com Medication Guide. Website. https://www.drugs.com/apps/. Accessed November 12, 2018.
- National Cancer Institute. A to Z List of Cancer Drugs. Website. www.cancer.gov/about-cancer/treatment/drugs. Accessed November 12, 2018.
- National Cancer Institute. FDA Approvals - Cancer Currents Blog. Website. www.cancer.gov/news-events/cancer-currents-blog/fda-approvals. Accessed November 12, 2018.
- American Association for Cancer Research Foundation. FDA Approvals. Website. www.aacrfoundation.org/approvals/Pages/default.aspx. Accessed November 12, 2018.
- ASCO Practice Central. Oncology Practice Insider. Website. https://practice.asco.org/oncology-practice-insider?tid=14. Accessed November 12, 2018.