FDA Fast Tracks Malignant Pleural Mesothelioma Drug

A cancer vaccine designed to treat malignant pleural mesothelioma, known as galinpepimut-S, or the WT1 cancer vaccine, recently obtained a Fast Track designation from the U.S. Food and Drug Administration. This designation means that the FDA will conduct an expedited review of the drug in order to potentially speed its approval.

Attacking the WT1 Protein

The vaccine targets the WT1 protein, with is typically found in cancer cells in high numbers and is resistant to standard forms of chemotherapy.

The vaccine is regarded as a “second-line” treatment to supplement the first-line treatment, for the disease, which typically consists of a combination of surgery, radiation and chemotherapy. If this vaccine proves to be a successful second-line treatment, survival rates will likely increase.

The FDA granted the vaccine “orphan drug” status earlier this year after a clinical trial proved promising. The orphan drug designation is meant to help speed the development of drugs for rare diseases such as malignant pleural mesothelioma.

Patients in the clinical trial survived an average of nearly 25 months, compared to the average survival rate of about 16 months for those who were not given the vaccine. A more extensive trial is scheduled for next year. Whereas the original trial consisted of participants receiving six vaccine injections every two weeks, the new trial will include booster injections as well as up to 12 vaccinations.

The WT1 vaccine could also help treat multiple myeloma, brain cancer and ovarian cancer.