Browsing items tagged “United States | 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 […]

FDA Approves BMS’ Opdivo for Advanced ESCC After Chemotherapy

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #bms #escc #esophagealcancer #fda #priorityreview PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), following prior fluoropyrimidine- and platinum-based chemotherapy Approval from the U.S. regulator is based on results from […]

Medicare Beneficiaries Granted Lower OOP Insulin Costs Under Part D Senior Savings Model

Region: NORTH AMERICA | Type: Policy | Keywords: #cms #copayment #diabetes #insulin #lowercosts #medicaid #medicare #oopcosts #partdseniorsavings PRICENTRIC BRIEF: The Centers for Medicare & Medicaid (CMS) announced that over 1,750 standalone Medicare Part D prescription drug plans and Medicare Advantage plans with prescription drug coverage applied to offer lower insulin costs under the Part D Senior Savings Model for the 2021 plan year Through this, participating plans will provide […]

FDA Grants Enhertu Orphan Drug Designation for Gastric Cancer

Region: NORTH AMERICA | Type: Regulation | Keywords: #astrazeneca #daiichisankyo #deruxtecan #enhertu #orphan #trastuzumab PRICENTRIC BRIEF: The FDA has granted Orphan Drug Designation to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of patients with gastric cancer, including gastroesophageal junction cancer The designation was supported by data from the Phase II DESTINY-Gastric01 trial, in which Enhertu demonstrated a statistically significant and clinically meaningful improvement in objective response […]

Deciphera’s Qinlock Approved for Fourth-Line GIST Treatment by FDA

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #deciphera #fda #projectorbis #qinlock #realtimeoncologyreview PRICENTRIC BRIEF: The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.) The New Drug Application (NDA) […]

Minnesota to Require Drugmakers to Justify Price Hikes

Country: UNITED STATES | Region: NORTH AMERICA | Type: Regulation | Keywords: #minnesota #priceincrease #proposal PRICENTRIC BRIEF: Aiming to cut down on price hikes, the Minnesota House of Representatives approved a proposal ordering drug manufacturers to justify large increases in prescription drug costs, and Gov. Tim Walz is expected to sign the measure into law The bill would require drug manufacturers that priced prescriptions drugs at […]

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 […]

ICER Analysis of Vertex’s 4 CFTR Modulators Hails Benefit of Trikafta but Suggests 73% Discount

Country: UNITED STATES | Region: NORTH AMERICA | Type: Cost Effectiveness | Keywords: #cftrmodulator #clinicaleffectiveness #drugprices #healthbenefitpricebenchmark #icer #value #vertex PRICENTRIC BRIEF: The Institute for Clinical and Economic Review (ICER) published its assessment of the comparative clinical effectiveness and value of Vertex’s four CFTR modulators for cystic fibrosis (CF): Trikafta (elexacaftor/tezacaftor/ivacaftor), Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), and Symdeko (tezacaftor/ivacaftor) David Rind, MD, ICER’s Chief Medical Officer, explained that findings showed Trikafta […]

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 […]

FDA Publishes Final Rule on New Regulatory Pathway Shift for Insulin, Other Biologics

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #biologicdrugs #biosimilar #fda #insulin #regulation PRICENTRIC BRIEF: On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulin and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act For the first […]