- By Alberto Abaterusso
On Nov. 4, AbbVie announced that Veliparib, a PARP inhibitor, received the Orphan Drug Designation status from the U.S. Food and Drug Administration (FDA), for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
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The status of "orphan drug" is usually assigned to those medications that are potentially useful to treat a rare disease that has a low frequency in the population.
The designation encourages pharmaceutical companies to test the medication in clinical trials. Companies receive some incentives after their orphan drug has received the FDA approval, consisting of a series of tax reductions and the exclusivity to commercialize the product for a period up to seven years after being launched on the market.
Despite radiotherapy and chemotherapy that indiscriminately attack all cells, cancer and healthy ones, these medications known as PARP inhibitors only attack those cells that are ill because they target the DNA of the cancer.
These PARP inhibitors have the function of preventing cancer cells from repairing themselves after they have been damaged by the radiotherapy and chemotherapy and then become resistant to the chemotherapy drugs whose function is instead to attack the DNA of cancer cells and cause their death.
The PARP inhibitors block a particular molecule that is involved in the repair process of the tumor cells.
Non-small-cell lung carcinoma (NSCLC) is a type of lung cancer, which is generally treated either with surgery (pulmonary lobectomy or pneumonectomy) or radiotherapy and chemotherapy.
"Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers," according to Medscape. "Aquamous cell carcinoma accounts for about 25 to 30 percent of NSCLC cases. It is usually found in the middle airways of the lungs and is often linked to a history of smoking," according to the American Cancer Society.
On Nov. 4, 2016, AbbVie closed $56.04, up 15 cents (0.27%), with a volume of 11,186,952 shares traded on the New York Stock Exchange. The stock lost 5.40% and was outperformed with 7.42% by the S&P 500 year to date.
This article first appeared on GuruFocus.
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