Download Date - UC Davis Health

April 1, 2009
IRB Director
Re: IND Waiver Determination for proposed protocol:
Predicting Femara® (Aromatase Inhibitor) Responsiveness in Endometrial Carcinoma
Dear Ms. X
The purpose of this submission is to request a confirmation of my determination that the above noted
protocol meets the requirements for exemption from the Investigational New Drug regulations, according
to 21 CFR 312.10 I believe the proposed research with Femara® meets the exemption requirements
noted in 21 CRF 312.10, specifically:
1. FEMARA is lawfully marketed in the United States by Novartis and has been so since January
2001. See Appendix 1 for Novartis’ current label.
2. This is an investigator initiated pilot study, please see Study Protocol in Appendix 2. It is not
intended to be reported to the FDA as a well-control study in support of the new indication.
3. This investigator initiated study is not substantial enough to change the current label.
4. The route of administration and the dose remains the same as currently listed on Femara’s label.
Both breast and endometrial cancers have estrogen-dependent forms. Women with endometrial
cancer are at increased risk for breast cancer and visa versa. Since the two populations of
women overlap in their risk profiles and susceptibility to estrogen driven oncogenesis, it is
extremely likely that the consequences of treatment of these populations with aromatase
inhibiting agents (e.g. Femara) will be very similar if not indistinguishable. The 2.5 mg oral daily
dose of Femara has been well characterized in clinical trials involving breast cancer patients.
Similar rates and types of side effects are anticipated in this group of endometrial cancer patients
who will receive a 2.5 mg oral daily dosage of Femara.
5. This study has been approved by the Femara Protocol Review Committee in Novartis. The study
protocol has been submitted to the UC Davis Cancer Center Scientific Review Committee and will
be submitted to UC Davis IRB before the study will start. UC Davis IRB procedures adhere to the
Common Rule regulations and holds the Federalwide Assurance Certificate..
6. The study participants will not be charged for the costs of drugs in this study and Investigator will
not represent in a promotional context that an investigational new drug is safe or effective for the
purposes for which it is under investigation or otherwise promote the drug.
Please see section [Reference to UC Davis IRB Consent Risk/Benefit section] for a description of
risk/benefit of this study.
Thank you in advance for your attention and consideration of this request.
Sincerely,
Lloyd H. Smith, MD, PhD
Professor and Chair
Department of Obstetrics and Gynecology
University of California Davis
4860 Y Street, Suite 2500
Sacramento, CA 95817
Attachments:
Appendix 1: Femara Current Label, dated September 2008
Appendix 2: Study Protocol Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma,
dated March 19, 2009
Appendix 3: Draft UC Davis IRB Consent Form
Appendix 4: Novartis Letter of Cross-Reference, dated March 9, 2009