(CBS News) — U.S. regulators have approved the first drug aimed at women with advanced breast cancer caused by an inherited flawed gene.
The Food and Drug Administration on Friday approved AstraZeneca PLC’s Lynparza for patients with inherited BRCA gene mutations who have undergone chemotherapy.
The drug has been on the market since 2014 for ovarian cancer, and is the first in a new class of medicines called PARP inhibitors to be approved for breast cancer. PARP inhibitors prevent cancer cells from fixing problems in their DNA.
Lynparza will cost $13,886 per month without insurance, according to AstraZeneca. The company is offering patients financial assistance.
“While there is currently no cure for metastatic breast cancer, today’s approval offers a new, targeted option that may help to delay disease progression for these patients,” Dr. Susan M. Domchek at the University of Pennsylvania’s Abramson Cancer Center said in a statement.
Until recently, cancer medicines targeted the disease based on where in the body it occurs.
This is a new approach to “target the underlying genetic causes of a cancer,” the FDA’s Dr. Richard Pazdur said in a statement.
The agency also approved a companion blood test from Myriad Genetic Laboratories Inc. for detecting BRCA mutations and determining which patients likely would benefit from Lynparza.
U.S. regulators have approved the first drug aimed at women with advanced breast cancer caused by an inherited flawed gene.
The Food and Drug Administration on Friday approved AstraZeneca PLC’s Lynparza for patients with inherited BRCA gene mutations who have undergone chemotherapy.
The drug has been on the market since 2014 for ovarian cancer, and is the first in a new class of medicines called PARP inhibitors to be approved for breast cancer. PARP inhibitors prevent cancer cells from fixing problems in their DNA.
Lynparza will cost $13,886 per month without insurance, according to AstraZeneca. The company is offering patients financial assistance.
“While there is currently no cure for metastatic breast cancer, today’s approval offers a new, targeted option that may help to delay disease progression for these patients,” Dr. Susan M. Domchek at the University of Pennsylvania’s Abramson Cancer Center said in a statement.
Until recently, cancer medicines targeted the disease based on where in the body it occurs.
This is a new approach to “target the underlying genetic causes of a cancer,” the FDA’s Dr. Richard Pazdur said in a statement.
The agency also approved a companion blood test from Myriad Genetic Laboratories Inc. for detecting BRCA mutations and determining which patients likely would benefit from Lynparza.
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