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Following Nivolumab, Pembrolizumab Receives EU Approval as First-Line for Melanoma
Merck (MSD) has announced that its PD-1 inhibitor pembrolizumab (Keytruda) was approved by the European Commission for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Merck (MSD) has announced that its PD-1 inhibitor pembrolizumab (Keytruda) was approved by the European Commission for the treatment of advanced (unresectable or metastatic) melanoma in adults. The approval followed review of data from 3 studies—KEYNOTE-001, KEYNOTE-002, and KEYNOTE-006—to evaluate the efficacy and safety of the drug in 1500 advanced melanoma patients. The drug can now be administered at a dose of 2 mg/kg once in 3 weeks to patients residing in the 28 EU member states.
The approval comes close on the heels of the EU approval of the other PD-1 inhibitor—nivolumab (Opdivo) developed by Bristol Myer’s Squibb (BMS). A BMS press release last month informed on the approval of nivolumab for the treatment of advanced melanoma in adults following an accelerated assessment by the Committee for Medicinal Products for Human Use.
Nivolumab has been assigned priority review for first line in melanoma by the US FDA, with a projected action date of August 27, 2015. BMS submitted phase 3 results from the CheckMate-066 trial, in which the performance of treatment-naïve, advanced melanoma patients (with wild type Braf) on nivolumab was compared with that of patients on dacarbazine chemotherapy. Treatment with nivolumab improved overall survival (OS) by 58% and progression free survival (PFS) by 57% compared with dacarbazine.
Real-World Study Reveals Key Insights into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
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Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
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Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Many Patients With Psoriasis in Clinical Trials Experience Nocebo Effects, Study Finds
April 18th 2024Half of patients exposed to placebo in clinical trials experienced adverse events (AEs), which may be partially explainable by nocebo effects, according to a recent review and meta-analysis.
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Low-Volume Hospitals Had Higher Reoperation Rate, Postoperative Complications in CRC
April 18th 2024Patients opting for elective colorectal surgery to address colorectal cancer (CRC) could have different rates of reoperation and postoperative complications based on the size of the hospital.
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