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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O.: Intro by Dr. Richard PazdurResources for Information | Approved Drugs FDA D.I.S.C.O.: Intro by Dr. Richard Pazdur
  
  	
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*In our inaugural podcast, Dr. Richard Pazdur, director of the FDA Oncology Center of Excellence, talks with hosts Dr. Sanjeeve Bala and Dr. Abhilasha Nair about this new podcast series.*

Transcript:

Sanjeeve Bala: Welcome to the D.I.S.C.O.—the first Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence.

Abhi Nair: Hi, I’m Abhi Nair, an oncologist and medical officer here at the FDA.

SB: And I am Sanjeeve Bala, also an oncologist and medical officer at the FDA. The FDA Oncology Center of Excellence provides regulatory oversight for drugs, biologics, and devices in development for oncology indications in the United States. In our first soundcast, we have invited inaugural OCE director, Dr. Richard Pazdur, to talk about the new D.I.S.C.O. series. Dr. Pazdur, Director of FDA’s Office of Hematology and Oncology Products since 2000, has led the regulatory oversight for most modern oncology therapeutics. Welcome to the D.I.S.C.O., Dr. Pazdur.

Richard Pazdur: Glad to be here.

AN: Dr. Pazdur, tell us how this soundcast series came about and what D.I.S.C.O. is all about?

RP: My vision for these soundcasts is to get concise, timely information out to people who need these treatments, and who really use these treatments: that is, patients with cancer and their treating physicians.

RP: We had a meeting in 2015 with several practicing oncologists and we learned a lot from them, and what more we can do to reach them and help their patients. Since general oncologists, or oncologists in private practice, see the vast majority of patients with cancer in the United States, I want to be able to get them timely information on new treatments based on FDA’s thorough review process. As an oncologist who treated patients for more than 20 years, I know how important it is for the American people to have a greater number of safe and effective treatment options. I want them to know about these treatments.

SB: Thanks, Dr. Pazdur. Can you tell us about the types of oncology information the soundcasts will cover?

RP: The focus of D.I.S.C.O. soundcasts will be the new treatment, the indication, and any special considerations for the patient population for whom the drug is indicated. We will briefly discuss the clinical trial that was done to establish the treatment’s efficacy, including endpoints. It’s important to note that there is a large, multidisciplinary team that analyzes these applications that result in approval. So, we’re summarizing the work of many dedicated experts.

RP: From time to time, we will do soundcasts that are a bit different from the approval summaries. Occasionally, we will synthesize emerging information on specific cancers, such as soundcasts on lung cancer or breast cancer. I will also do a summary of the views from my role as the center’s director.

RP: Our hope is that through these soundcasts, we can further our mission of bringing safe and effective new cancer treatments to those people who need them most.

SB: Thank you, Dr. Pazdur.

RP: You’re welcome.

AN: The Drug Information Soundcast in Clinical Oncology, or D.I.S.C.O., will be released around the same time as some new product approvals. The soundcasts will be on the Oncology Center of Excellence website at www.FDA.gov/OCE, and also on iTunes. You can follow us on Twitter @FDAOncology to hear about our new soundcast releases. Also, you can tweet questions, comments, or suggest other topics to @FDAOncology.

AN: I’m Abhi Nair. Thanks for tuning in to the D.I.S.C.O.

SB: Until next time at the D.I.S.C.O., I’m Sanjeeve Bala.

Acknowledgements This Drug Information Soundcast in Clinical Oncology was developed by the following staff in the Oncology Center of Excellence and the Office of Hematology and Oncology Products: Sanjeeve Bala, Abhilasha Nair, Richard Pazdur, and Kirsten B. Goldberg. We would like to acknowledge the tremendous assistance of the FDA Division of Drug Information, Drug Safety Information podcast team: Catherine Chew, Kimberley Chiu, Steven Jackson, Sonia Kim, Mary E. Kremzner, Lesley Navin, and Raj Patel. We would also like to thank others who assisted in bringing this project to fruition: Andrea Frydl in the Office of Communications; the CDER web team of Helene Taira, Paul K. Stauffer, and Gail Wolfe; Josh Budich in the Division of Online Communications; and our OHOP colleagues Tony Cossentino, Amy E. McKee, Sherwin Sapasap, and Dianne Spillman.

                                                                                  Content current as of:
      05/17/2017
              
              
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  OncologyResources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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