Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
Sign Up to like & getrecommendations! Published in 2023 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2022.51564
Abstract: This cross-sectional study investigates the use of patient-reported outcome measures in new marketing authorizations for oncology drugs approved by the European Medicines Agency (EMA) between 2017 and 2021. read more here.
Keywords: oncology; oncology drugs; patient reported; outcome measures ... See more keywords
Oncofertility information available for recently-approved novel non-cytotoxic and immunotherapy oncology drugs.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2254
Abstract: We reviewed the available animal and human reproductive function studies of recently-approved non-cytotoxic oncology drugs. We reviewed the oncofertility information in the prescribing information for Food and Drug Administration (FDA)-approved products and/or the product information… read more here.
Keywords: oncofertility; information; recently approved; oncology drugs ... See more keywords
Second- and third-generation drugs for immuno-oncology treatment-The more the better?
Sign Up to like & getrecommendations! Published in 2017 at "European journal of cancer"
DOI: 10.1016/j.ejca.2017.01.001
Abstract: Recent success in cancer immunotherapy (anti-CTLA-4, anti-PD1/PD-L1) has confirmed the hypothesis that the immune system can control many cancers across various histologies, in some cases producing durable responses in a way not seen with many… read more here.
Keywords: second third; immuno oncology; oncology drugs; third generation ... See more keywords
Concurrent oral delivery of non-oncology drugs through solid self-emulsifying system for repurposing in hepatocellular carcinoma.
Sign Up to like & getrecommendations! Published in 2023 at "Drug development and industrial pharmacy"
DOI: 10.1080/03639045.2023.2216785
Abstract: OBJECTIVE Present study aimed to identify a safe and effective non-oncology drug cocktail as an alternative to toxic chemotherapeutics for hepatocellular carcinoma treatment. The assessment of cytotoxicity of cocktail (as co-adjuvant) in combination with chemotherapeutic… read more here.
Keywords: oncology; cell; oncology drugs; delivery ... See more keywords
DROID: Dose-ranging approach to optimizing dose in oncology drug development.
Sign Up to like & getrecommendations! Published in 2022 at "Biometrics"
DOI: 10.1111/biom.13840
Abstract: In the era of targeted therapy, there has been increasing concern about the development of oncology drugs based on the "more is better" paradigm, developed decades ago for chemotherapy. Recently, the US Food and Drug… read more here.
Keywords: oncology; oncology drugs; dose ranging; development ... See more keywords
Do elderly and young patients derive similar relative survival benefits from novel oncology drugs? A systematic review and meta-analysis.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2017.35.15_suppl.10029
Abstract: 10029Background: Elderly patients are commonly believed to derive less benefit from cancer drugs, even if they fulfil clinical trial eligibility. We aim to examine if novel oncology drugs provide d... read more here.
Keywords: patients derive; young patients; oncology drugs; elderly young ... See more keywords
Cost of oncology drugs in the Middle-Eastern country of Lebanon: An update (2014-2016).
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2018.36.15_suppl.e18917
Abstract: e18917Background: Lebanon is facing a mounting burden from cancer with heavy financial consequences on the healthcare system. This study aims to evaluate increasing trends in the cost of oncology d... read more here.
Keywords: oncology drugs; drugs middle; cost oncology; middle eastern ... See more keywords
Veterinarians should understand what it means to use conditionally approved drugs, with a focus on conditional approval of companion animal oncology drugs.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of the American Veterinary Medical Association"
DOI: 10.2460/javma.22.05.0205
Abstract: The purpose of this article is to provide veterinarians with an understanding of what it means to use a conditionally approved drug. This article summarizes information that has been used to satisfy the reasonable expectation… read more here.
Keywords: oncology; oncology drugs; approval; conditionally approved ... See more keywords
Patient-reported outcomes labeling for oncology drugs: Multidisciplinary perspectives on current status and future directions
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Pharmacology"
DOI: 10.3389/fphar.2022.1031992
Abstract: Introduction: Regulatory agencies encourage the incorporation of the patient voices throughout clinical drug development. Patient-Reported Outcomes (PROs) offer one way of doing this and their use has markedly increased in many therapeutic areas, particularly oncology,… read more here.
Keywords: reported outcomes; oncology; oncology drugs; patient reported ... See more keywords
Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021
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DOI: 10.3390/curroncol29110635
Abstract: Real-world evidence (RWE) is health and outcomes data generated from a patient’s journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisions.… read more here.
Keywords: oncology; oncology drugs; reimbursement; status ... See more keywords