The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to a promising pleural mesothelioma treatment: galinpepimut-S. This designation indicates that the FDA wants to get this mesothelioma treatment to patients as quickly as possible.

Galinpepimut-S, also known as the WT1 vaccine, is being developed by a company called SELLAS Life Sciences Group. They have also been testing the vaccine in several other types of cancer.

About Galinpepimut-S

Galinpepimut-S falls under the category of immunotherapy treatment. Immunotherapy treatments work with the body’s natural immune responses to battle a disease.

Galinpepimut-S is also known as the WT1 vaccine because of the antigen it works against. The WT1 antigen is common in cancers but not common in normal adult tissues. The goal of the vaccine is to convince the immune system to protect the body from the WT1 antigen. Since mesothelioma is high in WT1, the immune system will attack the cancer.

SELLAS announced earlier this year that pleural mesothelioma patients participating in the phase II trial of galinpepimut-S had a median overall survival of 24.8 months.

For comparison, the control arm in the trial only resulted in a median overall survival of 16.6 months. The treatment was also well tolerated by patients.

The Future of Galinpepimut-S Trials

Thanks to the fast track designation, researchers believe they will be able to start a phase III
clinical trial for galinpepimut-S next year.

“We are excited to begin the pivotal Phase 3 trial in patients with [malignant pleural mesothelioma] in the second half of 2017 and expect the Fast Track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication,” Dr. Angelos M. Stergiou, Vice Chairman and CEO of SELLAS, said in a press release.

What Does Fast Track Designation Mean?

A fast track designation is given by the U.S. Food and Drug Administration (FDA). According to the FDA, “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.” The fast track helps the FDA get the most promising drugs to patients who need them most.

“This Fast Track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma,” Dr. Stergiou said.

Mesothelioma is a serious condition and few treatments are available for patients. In fact, only one treatment is FDA approved for mesothelioma: chemotherapy with alimta and cisplatin. This one option doesn’t work for all patients. A new treatment option like galinpepimut-S would fill an unmet need for mesothelioma patients.

Drugs that receive fast track designation receive some or all of these benefits:

  • More frequent meetings and written communications with the FDA
  • Possible Accelerated Approval or Priority Review from the FDA
  • Rolling Review, which means the drug company can have parts of certain applications reviewed as they go rather than waiting for them all to be completed.
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    Sources & Author

  1. SELLAS™ Life Sciences Receives FDA Fast Track Designation of Galinpepimut-S for the Treatment of Malignant Pleural Mesothelioma. SELLAS Life Sciences Group. Retrieved from: Accessed: 09/30/16.
  2. Fast Track. U.S. Food & Drug Administration. Retrieved from: Accessed: 09/30/16.
  3. WT1 Cancer Vaccine. SELLAS Life Sciences Group. Retrieved from: Accessed: 09/30/16.
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About the Writer, Jamie Iovino

Jamie Iovino is the senior writer at Mesothelioma Guide. She creates and edits pages to make sure mesothelioma patients and their families receive the newest and most accurate information about mesothelioma.