Browsing items tagged “Merck | EVERSANA”

Merck’s Keytruda Secures Metastatic Colorectal Cancer Approval from FDA

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #fda #merck #msd #oncologycenterofexcellence #projectorbis #realtimeoncologyreview #rtor PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda (pembrolizumab) as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer Approval from the FDA is based on results from the Phase 3 KEYNOTE-177 trial […]

ICER Publishes Draft Evidence Review for Ulcerative Colitis – Pfizer, Janssen, Merck, AbbVie, and Takeda Impacted

The Institute for Clinical and Economic Review published their Draft Evidence report for what could be one of the biggest reviews of 2020. The review of Ulcerative Colitis (UC) impacts big players in Immunology – all of which will need to bring their A-Game to this class review. Due to COVID-19, the meeting will be […]

FDA OK’s AZ & Merck’s Lynparza Plus Bevacizumab in HRD-Positive Ovarian Cancer

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #astrazeneca #fda #merck PRICENTRIC BRIEF: Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and […]

FDA Grants Priority Review to Merck’s Keytruda, Use Based on Biomarker Regardless of Tumor Type

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #biomarker #fda #immunotherapy #merck #priorityreview PRICENTRIC BRIEF: The application is for Merck’s Keytruda (pembrolizumab) as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) greater than or equal to 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment […]