The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024. The sBLA is based on data from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Seagen and Astellas, in which KEYTRUDA plus...
Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% ...
is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe anticipated clinical benefits of Keytruda, and the sponsor is currently conducting these studies in additional patients with M...
When surgery is required, importance of informing the attending physician, dentist, or anesthesiologist of recent (within 12 months) glucocorticoid therapy. In immunosuppressed patients, importance of avoiding exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining...
The efficacy of checkpoint inhibitor (CPI) immunotherapy in patients with non–small cell lung cancer (NSCLC) is limited by a lack of strongly predictive response markers, subjecting patients to potential underutilization of alternative effective treatments, increased risk for futile care, and unnecessar...
The judge disagreed, reasoning that the information sought was part of an investigational drug application that is designed to be kept confidential to protect the trade secrets and commercial information of the drug developer. Keytruda fails late-stage liver cancer trial — Merck reported its dru...
Pembrolizumab (Keytruda) Atezolizumab (Tecentriq) Durvalumab (Imfinzi) CTLA-4 inhibitors Cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors block the CTLA-4, a protein on T-cells which inhibits the T-cell’s immune response. The FDA-approved CTLA-4 in combination with nivolumab is: ...
The resulting number is communicated as mutations per Mb unit (mut/Mb). Per the F1CDx assay, a patient whose tumor has a TMB ≥ 10 mut/Mb is reported as eligible for treatment with KEYTRUDA: After completion of the Analysis Pipeline, variant data are displayed in the FMI custom-developed...
MERCK. FDA approves KEYTRUDA® (pembrolizumab) for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy. 2015.http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-appro...
Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and wit...