AbbVie's experimental lung cancer drug veliparib has picked up Orphan Drug status in the US, opening the door to potential tax credits, waived fees, protocol assistance and exclusivity benefits.
Veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, is being investigated in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
PARP is a naturally-occurring enzyme in the body that repairs damage to DNA in cells. This process may also help repair DNA in cancer cells, helping their survival. Researchers are looking at whether veliparib, in combination with DNA damaging therapies, could hinder this damage repair mechanism and thus facilitate cancer cell death.
"Lung cancer is the leading cause of cancer-related deaths in the US and can be difficult to treat, particularly when diagnosed in later stages, said Michael Severino, executive vice president of R&D and chief scientific officer at AbbVie. "This Orphan Drug Designation for veliparib recognises the significant unmet need in patients with advanced squamous non-small cell lung cancer."