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Tatiana M. Prowell, M.D.

Tanya Michelle Prowell, M.D.

Photo of Dr. Tatiana M. Prowell, M.D.

Part-time Medical Oncology Faculty

Assistant Professor of Oncology

Female

Expertise: Breast Cancer, Medical Oncology

Research Interests: Triple-negative breast cancer; Novel therapies for breast cancer; Breast cancer in young women; Neoadjuvant therapy for breast cancer ...read more

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Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Appointment Phone: 410-955-8964

401 N. Broadway
Baltimore, MD 21231 map
Phone: 410-955-8893

Background

Dr. Prowell received her B.A. degree in Languages & Literature with honors from Bard College. She received her M.D. degree from Johns Hopkins University School of Medicine in Baltimore, Maryland, where she was elected to the Phi Beta Kappa and Alpha Omega Alpha honor societies. She subsequently completed an internal medicine residency in the Osler Housestaff Training Program at Johns Hopkins Hospital and a medical oncology fellowship within the Breast Cancer Research Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital. During fellowship, she wrote and conducted three investigator-initiated translational breast cancer trials. Dr. Prowell was awarded a Young Investigator Award from the American Society of Clinical Oncology (ASCO) and twice awarded the Pearl M. Stetler Research Fund for Women for her breast cancer research.

In 2006, Dr. Prowell accepted a joint appointment as faculty at the Johns Hopkins School of Medicine in the Breast Cancer Program and as a Medical Officer at the FDA.  She currently serves as the Scientific Lead for Breast Cancer in the Office of Hematology & Oncology Products at the FDA and is an Assistant Professor of Oncology in the Johns Hopkins Breast Cancer Program.  Dr. Prowell has been an invited speaker at numerous academic institutions, national medical conferences, and patient advocacy gatherings and is a three-time recipient of FDA's Excellence in Communication Award.  Recently she has helped to pioneer a pathway to accelerated approval for drugs used to treat patients with high-risk, early-stage breast cancers, such as triple-negative breast cancer, in the neoadjuvant setting.

Dr. Prowell remains committed to the clinical care of women and men with breast cancer and practices at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, where she staffs the second opinion breast cancer clinic.  Her particular areas of clinical and research interest include:  triple-negative breast cancer, development of novel agents for breast cancer treatment, neoadjuvant therapy for breast cancer, and the unique challenges of breast cancer in younger women. 

Dr. Prowell is passionate about her work.  When asked what motivated her to pursue the joint appointment she currently holds at Johns Hopkins and the FDA, Dr. Prowell said, "The two positions really complement one another.  In my clinical practice, I have the privilege of spending as much time as it takes to help my patients make the most informed choices possible about their treatment.   I see the challenges that my patients face up close, and I feel the urgency to get novel therapies to them.  At the FDA, I have the opportunity to shape at a very high level drug development programs to ensure that the most promising treatments will reach patients as rapidly as possible.  I love what I do.  I feel thankful every day to wear both of these hats as an oncologist to make things better for patients living with this disease.  I couldn't imagine doing anything different."  She pauses before adding, "though I would be very happy to be put out of business.  I guess if we do our jobs well enough, that's precisely what will happen!  I hope I live to see that day."

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Titles

  • Part-time Medical Oncology Faculty
  • Assistant Professor of Oncology

Departments / Divisions

Centers & Institutes

Education

Degrees

  • MD, Johns Hopkins University School of Medicine (1999)

Residencies

  • Johns Hopkins University School of Medicine / Internal Medicine (2002)

Fellowships

  • Johns Hopkins University School of Medicine / Oncology (2006)

Board Certifications

  • American Board of Internal Medicine / Internal Medicine (2002, 2012)
  • American Board of Internal Medicine / Medical Oncology (2004)

Research & Publications

Clinical Trial Keywords

breast cancer

Selected Publications

  1. Prowell T, Smith B. Neutropenic Fever. In: Cheng A, Zaas A., eds. The Osler Medical Handbook, First Edition. Philadelphia: Mosby, 2003: 537-544.
  2. Prowell T, Liu M. Asthma. In: Cheng A, Zaas A., eds. The Osler Medical Handbook, First Edition. Philadelphia: Mosby, 2003: 867-880.
  3. Prowell T, Davidson N. What is the role of ovarian ablation in the management of primary and metastatic breast cancer today? The Oncologist 2004; 9(5): 507-517.
  4. Prowell T, Stearns V. Commentary on: "Are breast density and bone mineral density independent risk factors for breast cancer?" (Kerlikowske et al, J Natl Cancer Inst 2005;97:368-374). The North America Menopausal Society (NAMS): First to Know. April 2005. www.menopause.org/news.html
  5. Sheth A, Prowell T, Krishnan J. Asthma. In: Nilsson K, Piccini J., eds. The Osler Medical Handbook, Second Edition. Philadelphia: Saunders Elsevier, 2006: 865-876.
  6. Prowell T, Stearns V, Trock B. Lipophilic statins merit additional study for breast cancer chemoprevention. Journal of Clinical Oncology, 2006; 24(13): 2128-2129.
  7. Prowell T, Stearns V. Disease-free survival was greater with letrozole than tamoxifen in postmenopausal women with early breast cancer. ACP Journal Club, 2006: 145(1): 11.
  8. Bao T, Prowell T, Stearns V. Chemoprevention of breast cancer: Tamoxifen, raloxifene, and beyond. American Journal of Therapeutics, 2006; 13(4): 337-348.
  9. Prowell T, Davidson N. Metastatic breast cancer: Tailored endocrine therapy for premenopausal women. In: Piccart M, Wood W, Hung M-C, Solin L, Cardoso F., eds. Breast Cancer Management and Molecular Medicine: Towards Tailored Approaches. Springer-Verlag, 2006: 445-458.
  10. Prowell T, Armstrong D. Selecting endocrine therapy for breast cancer: What role does HER-2/neu status play? Seminars in Oncology, 2006; 33(6): 681-687.
  11. Prowell T, Stearns V. Extended adjuvant therapy for breast cancer—how much is enough? J Natl Cancer Inst. 2007 99: 1825-1827.
  12. Prowell T, Fackler M, Argani P, Khouri N, Blackford A, Shahverdi K, Wolff A, Davidson N, Sukumar S, Stearns V. A prospective study of adjuvant anastrozole and gene promoter methylation in the contralateral breast of high-risk women. J Clin Oncol 26: 2008 (May 20 suppl; abstr 1514).
  13. Bao T, Shahverdi K, Blackford A, Prowell T, Jeter S, Powers P, Wright L,. Snyder C, Stearns V, Visvanathan K.Quality of life changes in breast cancer patients participating in an anastrozole secondary prevention trial.J Clin Oncol 26: 2008 (May 20 suppl; abstr 1515).
  14. Prowell T, Ibrahim A, Farrell A, Justice R, Sun Mitchell S, Sridhara R, and Pazdur R. FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma. The Oncologist 2010; 15:428-35.
  15. Prowell T, Blackford A, Byrne C, Khouri N, Dowsett M, Folkerd E, Tarpinian K, Powers P, Wright L, Donehower M, Jeter S, Armstrong D, Emens L, Fetting J, Wolff A, Garrett-Mayer E, Skaar T, Davidson N, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res 2011; 4:1993-2001.
  16. Higgins M, Prowell T, Blackford A, Byrne C, Khouri N, Slater S, Jeter S, Armstrong D, Davidson N, Emens L, Fetting J, Powers P, Wolff A, Green H, Thibert J, Rae J, Folkerd E, Dowsett M, Blumenthal R, Garber J, Stearns V. A Short-Term Biomarker Modulation Study of Simvastatin in Women at Increased Risk of a New Breast Cancer. Breast Cancer Res Treat 2012; 131: 915-924
  17. Prowell T, Pazdur R. Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer. N Engl J Med. 2012; 366:2438-41.
  18. Prowell T. Guidance for Industry: Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf.
  19. Zhang L, Untch M, Mehta K, Costantino J, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Zujewski J, Justice R, Loibl S, Wickerham L, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas E, Bergh J, Semiglazov V, Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain S, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, and von MinckwitzG. Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTneoBC). Cancer Res 2012;72 (24 Suppl):Abstract P114-20.
  20. Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain S, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, and von Minckwitz G. A Definition of a High-Risk Early-Breast Cancer Population Based on Data from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis. Cancer Res 2013; Abstract P5-17-01.
  21. Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain SM, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, vonMincwitz G. Pathological complete response in breast cancer: CTNeoBC pooled-analysis. The Lancet. Epub ahead of print Feb 14, 2014.

Activities & Honors

Honors

  • Asher B. Edelman Excellence and Equal Cost Scholarship (full academic scholarship), Bard College, 1990
  • Summer Intramural Research Training Award, NIH, 1993
  • Heinrich Blücher Scholar (for excellence in the Division of Languages and Literature), Bard College, 1993
  • Bishop-Jervis Prize (for four years of overall academic excellence), Bard College, 1994
  • Phi Beta Kappa Society, Johns Hopkins University, 1999
  • Alpha Omega Alpha Honor Medical Society, Johns Hopkins University School of Medicine, 1999
  • Pearl M. Stetler Research Fund Award, 2004
  • Young Investigator Award, American Society of Clinical Oncology, 2004
  • Pearl M. Stetler Research Fund Award, 2005
  • Award for Excellence in Communication, Food & Drug Administration, 2010
  • FDA Group Recognition Award, 2011
  • Award for Excellence in Communication, Food & Drug Administration, 2012
  • Award for Excellence in Communication, Food & Drug Administration, 2014

Memberships

  • American Society of Clinical Oncology

Videos & Media

Lectures and Presentations

  • Treatment with adjuvant anastrozole decreases cumulative gene methylation in the contralateral breast of women at increased risk for a second breast cancer.
    ASCO Breast Cancer Symposium; oral abstract presentation (Abstract 1) , San Francisco, CA (09/07/2007)
  • Why have we not prevented or cured breast cancer, and what are we going to do about it?
    Vision Panel Speaker, Collaborative Summit on Breast Cancer Research , Leesburg, VA (11/02/2007)
  • Write Your Ticket: Career Options in Medical Oncology--A Session for Fellows and Junior Faculty.
    ASCO Annual Meeting , Orlando, FL (06/05/2009)
  • Doxil in Advanced Breast Cancer.
    FDA Presentation, Oncology Drugs Advisory Committee Meeting , Gaithersburg, MD (07/15/2009)
  • Neoadjuvant Chemotherapy—Pros and Cons.
    The Fifth Bi-Annual Johns Hopkins Breast Cancer Conference , Baltimore, MD (03/27/2010)
  • FDA History and Regulatory Authority
    National Breast Cancer Coalition, Project LEAD Conference , Lansdowne, VA (11/04/2010)
  • Oncology Drug Development: A Regulatory Perspective
    Clinical Investigator Seminar Series, Dana Farber Cancer Institute , Boston, MA (03/22/2011)
  • Challenges in Oncology Drug Development.
    Presentation to Congressional Staff , Silver Spring, MD (03/28/2011)
    FDA
  • Clinical Trials Module, Accelerating Anticancer Agent Development and Validation (AAADV) Workshop
    Metastatic Breast Cancer Network National Conference , Bethesda, MD (05/18/2011)
  • Clinical Trials Versus Standard of Care.
    CBS Biocentury TV , Baltimore, MD (10/29/2011)
  • FDA and Cancer: The Inside View.
    Clinical Investigator Seminar Series, Dana Farber Cancer Institute , Washington, DC (02/05/2012)
  • Regulatory Considerations in Oncology Drug Development.
    The Sixth Bi-Annual Johns Hopkins Breast Cancer Conference: Controversies in Management—A Multidisciplinary Perspective , Boston, MA (03/05/2012)
  • Are Anthracyclines Past Their Prime?
    Accelerating Anticancer Agent Development and Validation (AAADV) Workshop , Annapolis, MD (03/30/2012)
  • Pitfalls in Oncology Drug Development.
    Topics in Clinical Medicine course, Johns Hopkins University School of Medicine , Bethesda, MD (05/16/2012)
  • Meet the Professor Session: Breast Cancer.
    American Society of Clinical Oncology (ASCO) Annual Meeting , Baltimore, MD (05/09/2012)
  • Emerging Concepts of Drug Safety in Oncology,
    iSPY2 Annual Investigators Meeting , Chicago, IL (06/01/2012)
  • Pathologic Complete Response as an Endpoint to Support Accelerated Approval,
    Grand Rounds, Medical Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins , Chicago, IL (06/01/2012)
  • Oncology Drug Development: A Regulatory Perspective.
    Webinar, Office of Medical Policy, Center for Drug Evaluation and Research, Food & Drug Administration , Baltimore, MD (06/22/2012)
  • Draft Guidance on Using Pathologic Complete Response as an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer.
    CBS Biocentury TV , Silver Spring, MD (06/28/2012)
  • Accelerating the Search for Breast Cancer Therapies for Triple Negative Breast Cancer.
    Cancer Policy Roundtable, National Coalition for Cancer Survivorship , Washington, DC (07/29/2012)
  • Regulatory Considerations in Oncology Drug Development.
    American Society of Clinical Oncology Leadership Development Program , Washington, DC (10/25/2012)
  • Strategies to Expedite Oncology Drug Development.
    Chemotherapy Foundation Symposium, Mt , Silver Spring, MD (11/07/2012)
  • Pathological Complete Response as an Endpoint to Support Accelerated Approval in High-Risk, Early-Stage Breast Cancer.
    Grand Rounds, Internal Medicine, Johns Hopkins Hospital , New York, NY (11/08/2012)
  • Exploiting the Preoperative Setting: Streamlining Drug Development in High-Risk, Early Stage Breast Cancer.
    Clinical Investigator Seminar Series, Dana Farber Cancer Institute , Baltimore, MD (01/04/2013)
  • Oncology Drug Development: A Regulatory Perspective.
    Breast Oncology Seminar Series, Dana Farber Cancer Institute , Boston, MA (03/05/2013)
  • Understanding the FDA Drug Approval Process in Breast Cancer: How It Works and How It Could Work Better.
    ASCO/FDA Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop , Boston, MA (03/06/2013)
  • Considerations for Neoadjuvant Breast Cancer Trials to Support Accelerated Approval.
    American Association for Cancer Research (AACR) Annual Meeting , Silver Spring, MD (03/22/2013)
  • Pitfalls in Oncology Drug Development.
    American Association for Cancer Research (AACR) Annual Meeting , Washington, DC (04/06/2013)
  • The Promise and Challenges of Pathological Complete Response (pCR) as a Novel Endpoint for Drug Approval in High-Risk, Early-Stage Breast Cancer.
    CASE Seminar on Drug-Induced Peripheral Neuropathy , Washington, DC (04/08/2013)
  • Drug-Induced Peripheral Neuropathy in Cancer Patients.
    Accelerating Anticancer Agent Development and Validation (AAADV) Workshop , Silver Spring, MD (04/11/2013)
  • Pitfalls in Oncology Drug Development.
    American Society of Clinical Oncology (ASCO) Pre-Annual Meeting, New Drugs in Oncology Seminar , Bethesda, MD (05/08/2013)
  • Clinical Trials with Molecular Selection: Neoadjuvant Trial Design.
    American Society of Clinical Oncology (ASCO) Annual Meeting , Chicago, IL (05/30/2013)
  • Impact of Phase I Trials on Safety and Optimal Dose for Future Clinical Practice.
    in Pushing the Limits of Upfront Care and Drug Development: Neoadjuvant Opportunities in Breast Cancer , Chicago, IL (06/01/2013)
  • Understanding the U.S. FDA Guidance on Pathological Complete Response and Accelerated Approval
    I-SPY 3 Planning Meeting , Chicago, IL (06/01/2013)
    American Society of Clinical Oncology (ASCO) Annual Meeting
  • Implementation of the Final Guidance on Accelerated Approval in the Neoadjuvant Setting.
    Breast Oncology Multidisciplinary Seminar , Washington, DC (11/15/2013)
  • Pertuzumab for High-Risk, Early Breast Cancer.
    Breast Oncology Multidisciplinary Seminar , Baltimore, MD (11/20/2013)
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Compassionate Use of Investigational Agents.
    Johns Hopkins University School of Medicine Ethics Course , Baltimore, MD (12/18/2013)
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Ethics of Oncology Drug Development.
    Norris Cotton Cancer Center Grand Rounds (02/12/2014)
  • Preoperative Systemic Therapy for Breast Cancer: Considerations for Investigators, Clinicians, and Patients.
    The Seventh Bi-Annual Johns Hopkins Breast Cancer Conference- A Multidisciplinary Perspective , Baltimore, MD (02/18/2014)
       Dartmouth-Hitchcock Medical Center
  • Pathological Complete Response: Is It the Holy Grail?
    Clinical Investigator Seminar Series, Dana Farber Cancer Institute , Boston, MA (03/07/2014)
  • Oncology Drug Development: A Regulatory Perspective.
    Massachusetts General Hospital (03/25/2014)
  • Pathological Complete Response: Promise, Perils, and the Path Forward.
    American Association for Cancer Research (AACR) Annual Meeting , Boston, MA (03/25/2014)
  • Use of Biopsies for Clinical and Regulatory Decision-Making in Late-Stage Drug Development.
    San Diego, CA (04/07/2014)
  • Successful Oncology Drug Development: Balancing Knowledge, Speed, and Risk.
    American Association for Cancer Research (AACR) Annual Meeting , San Diego, CA (04/08/2014)
  • From Drug Activity to Meaningful Clinical Benefit.
    Accelerating Anticancer Agent Development and Validation (AAADV) Workshop , Bethesda, MD (05/07/2014)
  • Access to Data from Clinical Trials: A New Age of Clinical Trial Transparency.
    American Society of Clinical Oncology (ASCO) Annual Meeting , Chicago, IL (06/01/2014)

Recent News Articles and Media Coverage

How FDA''s pCR guidance may affect new drugs for triple-negative breast cancer http://www.biocentury.com/biotech-pharma-news/regulation/2012-07-23/how-fdas-pcr-guidance-may-affect-new-drugs-for-triple-negative-breast-cancer-a13

CBS Biocentury Show Breast Cancer:  Starting Earlier  http://www.biocenturytv.com/player/1758011648001/1759647506001

FDA To Let Women Try New Breast Cancer Drugs Earlier  http://www.reuters.com/article/2012/06/03/us-cancer-trials-fda-idUSBRE85208720120603

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