FDA Puts Mesothelioma Drug Galinpepimut-S on Approval Fast-Track

The U.S. Food and Drug Administration (FDA) has good news for people with mesothelioma.

The FDA is cutting some red tape so that the anti-mesothelioma drug galinpepimut-S can become available in the United States.

The FDA’s decision won’t make galinpepimut-S available overnight. It just helps speed things up so that the drug can become available sooner.

Galinpepimut-S is a mesothelioma vaccine. However, it’s not the type of vaccine that keeps you from getting mesothelioma.

What it does is help your body’s immune system fight on its own against mesothelioma. This is known as immunotherapy.

Galinpepimut-S is designed to work if you have the pleural type of mesothelioma. This type of mesothelioma starts by attacking the tissues that line and protect the outside of your lungs.

Mesothelioma Is Life-Threatening

The FDA’s decision about galinpepimut-S comes at a time when the vaccine is still being tested. The FDA has told SELLAS Life Sciences — the manufacturer of the drug — to keep testing but not to worry about some of the paperwork steps that would normally be required.

The FDA lets companies skip those steps if a drug is badly needed to fight a life-threatening disease. Mesothelioma is just such a disease.

But this FDA special permission doesn’t apply to every drug that’s badly needed. It applies just to those that show promise, like galinpepimut-S.

The special permission given to SELLAS is called fast-tracking. SELLAS said it now will make plans to move galinpepimut-S into a final round of tests. This testing will take the form of a Phase 3 clinical trial.

A large number of mesothelioma patients are expected to be enrolled in the clinical trial. SELLAS said it hopes to start this clinical trial sometime next summer.

SELLAS is currently wrapping up a Phase 2 clinical trial of galinpepimut-S. That trial had 40 mesothelioma patients in it.

The patients were treated with galinpepimut-S at two cancer clinics. One was Memorial Sloan Kettering Cancer Center in New York City. The other was M.D. Anderson Cancer Center in Houston.

SELLAS shared the Phase 2 results with cancer doctors at the 2016 Annual Meeting of the American Society of Clinical Oncology earlier this year.

The Phase 2 mesothelioma patients who were given galinpepimut-S had a median overall survival of 24.8 months. Mesothelioma patients not given galinpepimut-S had a median overall survival of 16.6 months.

Some of these mesothelioma patients had surgery before they started taking galinpepimut-S. The surgery was done to fully take out the mesothelioma tumors. The ones who received galinpepimut-S had generally good outcomes.

T Cells Attack Mesothelioma

The researchers involved in the Phase 2 clinical trial were excited to see that galinpepimut-S helped jump-start patients’ immune system T cells.

T cells are a type of white blood cell. Part of their job is to search out and destroy viruses roaming around inside your body. Another part of their job is to kill cancer cells.

Yet another part of their job is to tell other cells that also attack cancer cells to get in there and start killing.

However, mesothelioma makes T cells go to sleep so they can’t do these jobs. Galinpepimut-S wakes them up so they can do what they’re supposed to.

SELLAS Life Sciences is headquartered in Zug, Switzerland. It has an office in New York City. The company opened its doors in 2012 to develop innovative treatments for mesothelioma and other cancers.