Under their accelerated approval program, the FDA has approved two new drugs, Opdivo and Lynparza, to treat cancer . Both drugs are designed to treat patients with advanced stage cancer caused by specific gene mutations. The back to back approvals came due to impressive clinical trials that show tumor shrinkage in patients.
According to Richard Pazdur, M.D., director of the Office of Hermatology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, “The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life threatening diseases.”
On December 19th, the FDA approved Lynparza accompanied with a preliminary genetic test to show specific gene mutation. The first ovarian cancer drug of its kind, Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor designed for previously treated women with defective BRCA genes. Ordinarily, the genes help to repair damaged DNA and control the growth of tumors, but women with the mutation have an increased risk of ovarian cancer. An estimated 10 to 15 percent of all ovarian cancer is caused by the BRCA gene mutation. According the the National Cancer Institute, this year more than 20,000 American women will be diagnosed with ovarian cancer, and more than 14,000 will die from the disease. Trial data of Lynparza show that 34 percent of participants experienced tumor shrinkage for an average of eight months.
Days later, the FDA announced that it was approving Opdivo three months early. Opdivo is a treatment for inoperable or advanced melanoma, a type of skin cancer that forms in the cells that develop pigment. It is the fifth most common type of cancer. The National Cancer Institute predicts that in 2014 more than 75,000 Americans will be diagnosed with melanoma and more than 9,000 people will die from the disease. The seventh new melanoma drug since 2011, Opdivo works by restraining the programmed cell death 1 (or PD-1) protein, which prevents the immune system from attacking melanoma tumors. Clinical trials showed 32 percent of participants experienced tumor shrinkage.
Continuous research and medical innovations allow doctors to provide specialized treatment for cancer patients. While the prospect of personalized treatment with outstanding results is exciting, unfortunately cancer not only affects people physically but financially. Fifth Season Financial understands the economic hardship that can come with cancer treatment and can help you regain financial freedom through our Funds For Living Program.
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