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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
293
Tissue-Drug Binding: Localization of Drugs and its Significance01:24

Tissue-Drug Binding: Localization of Drugs and its Significance

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Body tissues, comprising approximately 40% of the body weight, are crucial in drug distribution and localization. These tissues can serve as drug storage sites, competing with plasma binding sites for drug molecules.
Drugs can bind to different tissue components, enhancing their distribution and localization. The factors influencing drug localization in tissues include the drug's lipophilicity, structural characteristics, tissue perfusion rate, and pH differences. These factors determine...
497
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Drug Distribution: Tissue Binding01:21

Drug Distribution: Tissue Binding

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Upon entering the systemic circulation, drugs can distribute into the interstitial and intracellular fluid of various tissue cells. This distribution is facilitated by the binding of drugs to different cellular components within tissues, which may lead to drug accumulation in specific areas. Drugs bound to tissue components serve as reservoirs that release free drugs back into the system, prolonging the drug's overall action. However, this accumulation can also result in local toxicity.
For...
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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
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Updated: Mar 1, 2026

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
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First Tissue-Agnostic Drug Approval Issued

    Cancer Discovery
    |June 7, 2017
    PubMed
    Summary

    Pembrolizumab, a PD-1 inhibitor, is now approved for solid tumors with specific biomarkers. This marks the first FDA approval based on a biomarker, not tumor type, for both adults and children.

    Area of Science:

    • Oncology
    • Immunotherapy
    • Genomics

    Background:

    • Mismatch repair deficiency (dMMR) and microsatellite instability-high (MSI-H) are key cancer biomarkers.
    • Targeted therapies are revolutionizing cancer treatment strategies.

    Purpose of the Study:

    • To report the accelerated approval of pembrolizumab for dMMR or MSI-H solid tumors.
    • To highlight the significance of biomarker-driven drug approval in oncology.

    Main Methods:

    • Review of FDA approval documentation for pembrolizumab.
    • Analysis of clinical trial data supporting the efficacy of pembrolizumab in dMMR/MSI-H tumors.

    Main Results:

    • Pembrolizumab received accelerated FDA approval for adult and pediatric patients.

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  • The approval is indicated for solid tumors exhibiting mismatch repair deficiency or microsatellite instability-high.
  • This represents a landmark decision, being the first FDA approval based on a biomarker rather than tumor histology.

    • Conclusions:

    • Biomarker-based drug approvals offer a personalized approach to cancer therapy.
    • The approval of pembrolizumab signifies a shift towards precision medicine in treating solid tumors.
    • This regulatory precedent may accelerate the development of other biomarker-directed cancer treatments.