TNBC - Expanded Access Protocol

BSI-201 EAP approved:
BiPar Sciences and sanofi-aventis recently obtained U.S. Food and Drug Administration (FDA) approval for an Expanded Access Protocol (EAP) for iniparib, the United States Adopted Name (USAN) for the investigational PARP1 inhibitor, BSI-201, in metastatic triple negative breast cancer (mTNBC).  Women in the United States with no comparable or satisfactory treatment options for mTNBC, and who do not qualify for an appropriate clinical trial, have the opportunity to access to the investigational compound iniparib through the EAP.  It is important to note that iniparib has not yet been approved by the FDA as safe and effective.

The company is now working with oncologists to open the EAP at sites around the country.  Sites will open at different times, depending on a variety of issues, including approval by local institutional review boards.  To enroll in the EAP, a woman must meet specific clinical criteria which her healthcare professional will assess.  A random selection process will ensure that all women with mTNBC who meet these criteria have equal opportunity to access the compound. 

Following the January 27, 2011 announcement by sanofi-aventis and its subsidiary, BiPar Sciences, that the Phase III study of iniparib in combination with gemcitabine/carboplatin in metastatic Triple Negative Breast Cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression free survival, modifications have been made to the Expanded Access Protocol (EAP) and to the current Named Patient Programme (NPP).

Patients currently on iniparib and in either of these programs (EAP or NPP) will be provided with information about the protocol modifications by their treating physician.  Patients who have concerns or questions should contact their physician for additional information.

Patients and health care professionals can learn more about the iniparib EAP at clinicaltrials.gov or by calling the information hotline +1 866 668 2232.

Background on iniparib and expanded access:
Iniparib is an investigational compound in clinical development.  Investigational compounds such as iniparib are not generally available until they are approved by the FDA.  However, the FDA has provisions to allow certain investigational compounds to be made available in cases where there are no comparable or satisfactory alternate therapies for serious or immediately life-threatening illnesses.  The primary goal of BiPar's iniparib development program is to provide regulatory authorities with scientifically valid information upon which to evaluate the safety and efficacy of this experimental compound.  Adhering to these rigorous requirements is essential to obtaining approval of any new product.

Investigational compounds such as iniparib may have unexpected serious side effects. It is important for women living with mTNBC to consider all the possible risks as well as the benefits if they are interested in seeking access to iniparib.  If you or a family member is interested in the EAP, please speak with a health care professional about whether the iniparib EAP may be an appropriate option.  Some patients may not qualify and certain doctors and institutions may be unwilling or unable to participate in the EAP.  There may not be enough supply of the investigational drug for all qualified patients.  The EAP may involve financial costs for qualified patients, and many insurance companies will not pay for access to an investigational compound. 

For additional helpful information about gaining access to an investigational agent through an EAP, please visit the FDA Website.