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Related Concept Videos

Targeted Cancer Therapies02:57

Targeted Cancer Therapies

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The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
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Combination Therapies and Personalized Medicine02:50

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Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
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FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.

Sundeep Agrawal1,2, Clara Lee2, William F Pierce2

  • 1Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|October 8, 2024
PubMed
Summary
This summary is machine-generated.

The U.S. Food and Drug Administration (FDA) updated capecitabine prescribing information, including new indications and safety details, through Project Renewal to ensure current, clinically relevant oncology drug guidance.

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Area of Science:

  • Oncology
  • Pharmacology
  • Regulatory Science

Background:

  • Capecitabine is an oral chemotherapy agent used in various cancer treatments.
  • Existing prescribing information requires regular updates to reflect current scientific knowledge and clinical practice.
  • The United States Prescribing Information (USPI) for older oncology drugs may not always be up-to-date.

Purpose of the Study:

  • To summarize the FDA's approach to revising the USPI for capecitabine.
  • To detail the updates made to capecitabine's indications, dosage, and safety information.
  • To contextualize these revisions within the FDA's Project Renewal initiative.

Main Methods:

  • Review and approval of supplemental New Drug Applications (NDAs) for capecitabine.
  • Evaluation of proposed revisions to existing indications and dosage regimens.
  • Assessment of updated safety information, including risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency.

Main Results:

  • The FDA approved revised USPI for capecitabine on December 14, 2022.
  • Updates included revised and new indications, updated dosage regimens, and enhanced safety information.
  • Specific attention was given to the risk of capecitabine in patients with DPD deficiency.

Conclusions:

  • The revisions ensure capecitabine prescribing information is clinically meaningful and scientifically current.
  • Project Renewal facilitates the modernization of prescribing information for older oncology drugs.
  • The updated USPI supports safe and effective use of capecitabine in cancer therapy.