The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
Blueprint Medicines’ Pralsetinib for Non-Small Cell Lung Cancer
Blueprint Medicines had a target action date of November 23, 2020 for pralsetinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The FDA approved it under the brand name Gavreto on September 4. The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. In addition to RET-altered NSCLC, it is being developed for RET-altered thyroid cancer and other solid tumors.