and Canada) that has been approved both in the U.S. Keytruda is an immune checkpoint inhibitor developed by Merck (known as MSD outside the U.S. applications for Keytruda in breast cancer, and we look forward to working closely with the FDA to bring these new options to patients as quickly as possible.” “The FDA’s acceptance of these Keytruda applications for review is an important step toward helping patients with both early-stage and metastatic disease,” Baynes said. “There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease,” Roy Baynes, senior vice president, head of global clinical development, and chief medical officer for Merck Research Laboratories, said in a press release. For this sBLA, the FDA set a PDUFA action date for March 29, 2021. Following the cancer’s surgical removal, these patients would then receive Keytruda alone as an adjuvant therapy - a treatment that seeks to prevent the cancer from returning. Neoadjuvant treatments aim to shrink a tumor before patients undergo surgery. The second sBLA, which was accepted for standard review, is requesting the approval of a neoadjuvant regimen of Keytruda and chemotherapy for the treatment of people with high-risk, early-stage TNBC.
Specifically, the combo therapy would be used in this indication to treat people with inoperable (locally recurrent unresectable) or metastatic TNBC, whose tumors have at least 10% of cells producing the PD-L1 protein. regulatory agency will make a decision by that date on whether to approve Keytruda, in combination with chemotherapy, as a treatment for TNBC.
#Keynote 355 license
One of the two supplemental biologics license applications (sBLAs) was granted priority review, which speeds FDA action, with a Prescription Drug User Fee Act ( Food and Drug Administration (FDA) has accepted to review two new Merck applications requesting the approval of Keytruda (pembrolizumab) for the treatment of patients with different forms of triple-negative breast cancer (TNBC).
0 kommentar(er)
