FDA grants fast track designation to galinpepimut-S for malignant plural mesothelioma

The FDA granted fast track designation to galinpepimut-S for the treatment of malignant pleural mesothelioma, according to the drug’s manufacturer.

“This fast track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma … [We] expect the fast track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication,” Angelos M. Stergiou, MD, vice chairman and CEO of SELLAS Life Sciences Group, said in a press release.

Galinpepimut-S (WT1 cancer vaccine, SELLAS Life Sciences Group) — a late clinical-stage immunotherapy — was evaluated in a randomized, double blind, placebo-controlled phase 2 study that included 40 patients with malignant pleural mesothelioma treated at Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.

Results — presented this year at the ASCO Annual Meeting and the International Mesothelioma Interest Group— showed median OS was 24.8 months among patients treated with galinpepimut-S compared with 16.6 months in the control arm. The survival benefit was even greater among patients with a complete tumor resection who were subsequently treated with galinpepimut-S.

Source: FDA grants fast track designation to galinpepimut-S for malignant plural mesothelioma


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