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 Check here to read about events on Capitol Hill, funding for rare-disease research, and other topics of interest from NORD's office in Washington, DC.
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Iniparib Expanded Access Program for Women with Metastatic Triple Negative Breast Cancer
BiPar Sciences and sanofi-aventis recently obtained U.S. Food and Drug
Administration (FDA) approval for an Expanded Access Protocol (EAP) for iniparib
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.
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. The company is working with experienced program partners,
including the National Organization for Rare Diseases (NORD), to ensure program
quality. Equity and timely access are the guiding principles for the program.
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.
If you are a patient interested in the trial, please call NORD at +1
866-668-2232. Healthcare professionals can learn more about the iniparib EAP at
clinicaltrials.gov
or by calling the company information hotline +1 866 668
2232.
About Triple Negative Breast Cancer
When patients are diagnosed with breast cancer, their tumors are routinely
tested for and classified by the presence of receptors or proteins that can
cause cancerous cells to grow and multiply. The three receptors most commonly
tested for are estrogen, progesterone and the human epidermal growth factor
receptor 2 (HER2). Patients with triple-negative breast cancer, or TNBC, test
negative for all three key receptors – hence the name triple-negative.
TNBC can be an aggressive disease, with higher rates of metastases and poorer
survival rates than other breast cancer subtypes. An estimated 10-15 percent of
all breast cancer cases diagnosed in the United States will be identified as
TNBC, accounting for 20,000-25,000 American women each year. Metastatic triple
negative breast cancer means that the tumor has spread beyond the original
organ. The prognosis is poor.
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