Washington, D.C. - The U.S. Food and Drug Administration (FDA) has decided to fast track Switzerland-based company SELLAS™ Life Sciences' new drug Galinpepimut-S to treat malignant pleural mesothelioma.
“This Fast Track designation underscores the importance of Galinpepimut-S as a potential treatment option in mesothelioma,” said Vice Chairman and Chief Executive Officer of SELLAS, Dr. Angelos M. Stergiou.
The FDA's Fast Track program only grants approval to new drugs that show promise in treating serious conditions such as cancer. It allows companies to have an expedited drug development process.
“SELLAS has made rapid progress against its strategic goals in the past six months, and this milestone follows the FDA’s Fast Track designation for AML, and recent orphan drug designation in the U.S. and Europe,” stated Dr. Stergiou.
This is especially exciting as the cost of treatment for pleural mesothelioma ranges from $100,000 to $150,000, on average. So far, the drug has shown a median overall survival of 24.8 months versus the control of 16.6 months.
The drug also induced CD8+ and CD4+ T-cell activation and garnered a favorable safety and tolerability profile. The results were presented at the ASCO Annual Meeting and the International Mesothelioma Interest Group.
The new drug is classified as a late clinical-stage immunotherapy treatment. It targets hematologic cancers and solid tumors. These include MPM, AML, multiple myeloma, ovarian, and other cancer types.
“Galinpepimut-S is demonstrating its potential as an anti-cancer agent with outstanding results regarding survival, immunological responses, and safety in AML and MPM patients,” said Dr. Stergiou.
The Phase II trial was randomized, double-blind, and placebo-controlled. Forty patients were involved at the Memorial Sloan Kettering Cancer Center and the M.D. Anderson Cancer Center. Come 2017, a Phase III trial will begin for patients with pleural mesothelioma.
“We are excited to begin the pivotal Phase III trial in patients with MPM 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,” said Dr. Stergiou.
SELLAS’ new drug is also in a clinical study to treat hematologic cancers and solid tumors, including acute myeloid leukemia, multiple myeloma, ovarian cancer, and other cancer types.