FDA Issues Draft Guidance on Targeted Drug Therapies - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Draft Guidance on Targeted Drug Therapies


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA issued a draft guidance for industry comment that contains proposed policy for diagnostic tests used with targeted drug therapies (i.e., personalized medicine). Companion diagnostics are used to help healthcare professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give, according to the press release about the guidance. The draft guidance discusses the agency’s plans for how it will review a companion diagnostic and its corresponding therapy.

The draft guidance defines a companion diagnostic and its use. According to the release, for example, looking for a specific gene amplicfication in a patient that may predict whether a drug would benefit that patient. Herceptin (trastuzumab), approved in 1998, for instance, targets HER2 gene amplification or HER2 protein over-expression in potential breast cancer patients. Herceptin “was approved with a companion test and today testing is routinely performed on women diagnosed with breast cancer to help health care professionals determine whether or not the patient should receive” it, says the release.

The draft guidance calls for early engagement between FDA and manufacturers so that the agency’s expectations can be included in development plans, and states that FDA will aim to conduct simultaneous reviews of a drug or biologic therapy and its corresponding companion diagnostic. The document also notes instances in which the agency may approve a targeted medicine in the absence of a cleared or approved companion diagnostic (e.g., in cases where the therapy is intended to treat a serious or life-threatening disease or condition for which there is no available or satisfactory treatment and when the potential benefits outweigh the risks of not having a cleared or approved companion diagnostic, states the release).

Comments on the draft guidance are due Sept. 12, 2011.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
25%
Attracting a skilled workforce
31%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here