FDA Approves New Treatment for Metastatic Pancreatic Cancer

The US Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, ablumin-bound (Abraxane) to treat patients with metastatic pancreatic cancer.

“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” said Richard Pazdur, MD, Office of Hematology and Oncology Products, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”

The drug is intended to be used with gemcitabine in patients with metastatic pancreatic cancer.

The FDA reviewed the new use for Abraxane under the agency’s 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.

In addition, participants who received Abraxane plus gemcitabine experienced a delay in tumour growth 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 included neutropenia, thrombocytopenia, peripheral neuropathy, alopecia, peripheral oedema), diarrhoea, fever, vomiting, rash, and dehydration.

The most common serious side effects were fever, dehydration, pneumonia, and vomiting. Other clinically important serious side effects included sepsis and pneumonitis.

SOURCE: US Food and Drug Administration