About Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Accelerated Approval for Neoadjuvant Chemotherapy in Breast Cancer

Font : A-A+

Accelerated Approval for Neoadjuvant Chemotherapy in Breast Cancer

The FDA has recently released a draft 'Guidance to Industry', outlining a pathway to accelerate the approval for newer chemotherapy drugs to be used as neoadjuvant therapies and seeking public comments on the use of 'pathological complete response' as an end point for this approval.

Neoadjuvant treatment for cancer is the chemotherapy or radiotherapy that a patient receives before definitive treatment like surgery. The addition of a pretreatment to surgery often results in better outcomes and lowers the chances of recurrence of the cancer following surgery.

Advertisement

A new drug to treat breast cancer is first tried out in patients with metastatic disease i.e. cancer that has spread to other organs. It is available for patients with early-stage disease only after years of clinical trials.  The drawback of this approach is that many patients miss the benefits of these new treatments. On the other hand, starting these drugs that have not undergone adequate clinical testing for safety may pose some risks in the form of side effects to the patient.

Taking the benefits and the possible disadvantages of using these chemotherapy drugs early, it has been suggested that these drugs could probably be tested first in those women with breast cancer who are more likely to have recurrence of the cancer following usual treatment. This includes women with high-grade tumors that are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) (these cancers are referred to as triple negative).
Advertisement

For such newer drugs, the manufacturer should be able to demonstrate that treatment with the new drug has eradicated cancer to the point where there is no indication of cancer in the breast or lymph nodes; this is referred to as a 'pathologic complete response'. Researchers suggested that chemotherapy drugs likely to produce a pathologic complete response should be granted accelerated approval.

The new drug could be added to an existing regimen and its benefits when used with the current regimen can be first demonstrated. Continued follow up would provide efficacy and safety data over a prolonged duration. If the patient is disease free over this period, then full approval may be granted. If the manufacturer is unable to establish the benefit, the additional indication may be withdrawn.

This process of accelerated approval would benefit the numerous women who are at a risk of recurrence of breast cancer following breast cancer surgery.

Reference :

Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer; Tatiana et al; N Engl J Med 2012; 366:2438-2441

Source: Medindia

Citations   close

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Dr. Simi Paknikar. (2012, July 21). Accelerated Approval for Neoadjuvant Chemotherapy in Breast Cancer. Medindia. Retrieved on Jun 27, 2022 from https://www.medindia.net/news/healthinfocus/accelerated-approval-for-neoadjuvant-chemotherapy-in-breast-cancer-104403-1.htm.

  • MLA

    Dr. Simi Paknikar. "Accelerated Approval for Neoadjuvant Chemotherapy in Breast Cancer". Medindia. Jun 27, 2022. <https://www.medindia.net/news/healthinfocus/accelerated-approval-for-neoadjuvant-chemotherapy-in-breast-cancer-104403-1.htm>.

  • Chicago

    Dr. Simi Paknikar. "Accelerated Approval for Neoadjuvant Chemotherapy in Breast Cancer". Medindia. https://www.medindia.net/news/healthinfocus/accelerated-approval-for-neoadjuvant-chemotherapy-in-breast-cancer-104403-1.htm. (accessed Jun 27, 2022).

  • Harvard

    Dr. Simi Paknikar. 2021. Accelerated Approval for Neoadjuvant Chemotherapy in Breast Cancer. Medindia, viewed Jun 27, 2022, https://www.medindia.net/news/healthinfocus/accelerated-approval-for-neoadjuvant-chemotherapy-in-breast-cancer-104403-1.htm.

Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
What's New on Medindia
COVID Toes
International Yoga Day 2022 - 'Yoga for Humanity'
Wearable Devices Are Now Transforming Depression, Multiple Sclerosis, and Epilepsy Management.
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Women and Cancer Breast Biopsy Pagets disease of the breast Mastitis Cancer and Homeopathy Chronic Lymphocytic Leukemia Hodgkins Lymphoma Non-Hodgkins Lymphoma Chemotherapy Chemotherapy Drugs 

Most Popular on Medindia

Vent Forte (Theophylline) A-Z Drug Brands in India Sanatogen How to Reduce School Bag Weight - Simple Tips Indian Medical Journals Pregnancy Confirmation Calculator Turmeric Powder - Health Benefits, Uses & Side Effects Calculate Ideal Weight for Infants The Essence of Yoga Nutam (400mg) (Piracetam)

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use