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Amgen's T-Vec Receives Poor FDA Staff Review
The accelerated review, the results of which were made public 2 days prior to a vote by an FDA advisory panel on using T-Vec in melaonma, cited concerns over the design and results of a key study with the viral drug.
FDA staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study.
The reviewers said in documents made public on Monday that it was unclear whether the treatment, a cancer-killing virus called talimogene laherparepvec or "T-Vec", improved overall survival, raising questions over its effectiveness. The review comes two days before a panel of FDA advisers votes on whether T-Vec should be approved to treat melanoma.
The FDA typically accepts the panel's recommendations.
Link to the Reuter's news:
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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