"Cervical cancer more commonly affects younger women and certain women of color in the U.S., and unfortunately, women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate," said Dr. For more information, see "Selected Important Safety Information" below. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.
KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously.
#KEYNOTE MAXIMUM ACTION DURATION PLUS#
Among patients who responded, the median duration of response (DOR) was 18.0 months (range, 1.3+ to 24.2+) for KEYTRUDA plus chemotherapy, with or without bevacizumab, and 10.4 months (range, 1.5+ to 22.0+) for chemotherapy, with or without bevacizumab. Additionally, more patients responded to KEYTRUDA plus chemotherapy, with or without bevacizumab, than to chemotherapy, with or without bevacizumab, with an objective response rate (ORR) of 68% (95% CI, 62-74) versus 50% (95% CI, 44-56), respectively. In this patient population, KEYTRUDA plus chemotherapy, with or without bevacizumab, demonstrated superior overall survival (OS HR=0.64 p=0.0001) and progression-free survival (PFS HR=0.62 p<0.0001) compared to chemotherapy, with or without bevacizumab, in patients whose tumors express PD-L1 (CPS ≥1).
#KEYNOTE MAXIMUM ACTION DURATION TRIAL#
The approval is based on the Phase 3 KEYNOTE-826 trial evaluating KEYTRUDA plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score ≥1) as determined by an FDA-approved test. KENILWORTH, N.J., October 13, 2021-( BUSINESS WIRE)-Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. This Is the First Anti-PD-1 Combination Approved as First-Line Treatment for These Patients
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