The Food and Drug Administration ( FDA ) has expanded the approved uses of Abraxane ( Paclitaxel protein-bound particles for injectable suspension, albumin-bound ) to treat patients with metastatic pancreatic cancer.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. An estimated 45,220 patients will be diagnosed and 38,460 will die from the disease in 2013, according to the National Cancer Institute ( NCI ).
Surgery is the only option to permanently remove or cure pancreatic cancer, but it usually is too late for surgery by the time the cancer is diagnosed.
Abraxane is a chemotherapy drug that can slow the growth of certain tumors. Abraxane is intended to be used with Gemcitabine ( Gemzar ), another chemotherapy drug, in patients with pancreatic cancer that has spread to other parts of the body.
The FDA reviewed the new use for Abraxane under the agencys priority review program, which provides for an expedited review of drugs. Abraxane was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition.
The safety and effectiveness of Abraxane for pancreatic cancer were established in a clinical trial with 861 participants who were randomly assigned to receive Abraxane plus Gemcitabine or Gemcitabine alone.
Participants treated with Abraxane plus Gemcitabine lived, on average, 1.8 months longer than those treated with Gemcitabine alone.
Additionally, participants who received Abraxane plus Gemcitabine experienced a delay in tumor growth ( progression-free survival ) that was, on average, 1.8 months later than the participants who only received Gemcitabine.
Common side effects observed in Abraxane plus Gemcitabine-treated participants include neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, rash and dehydration.
The most common serious side effects were fever, dehydration, pneumonia and vomiting.
Other clinically important serious side effects included bacterial infection of the blood stream ( sepsis ) and inflammation of the lung tissue ( pneumonitis ). ( Xagena )
Source: FDA, 2013