Review
Oncology
Shaily Arora, Preeti Narayan, Christy L. Osgood, Suparna Wedam, Tatiana M. Prowell, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Soma Ghosh, Reena Philip, Gwynn Ison, Tara Berman, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Summary: The treatment of patients with breast cancer has been greatly influenced by the approval of various drugs and indications in the past decade. This article summarizes the FDA approvals of 30 treatments for breast cancer from 2010 to 2020, including trial design, results, and regulatory considerations. The majority of approvals were for metastatic breast cancer, with a smaller number for early breast cancer. These approvals were primarily based on progression-free survival, overall survival, or objective response rate, and also involved other review initiatives and designations.
CLINICAL CANCER RESEARCH
(2022)
Review
Biochemistry & Molecular Biology
Alexander C. Martins, Fernando Albericio, Beatriz G. de la Torre
Summary: The year 2022 saw the successful control of the COVID-19 pandemic in most countries through social and hygiene measures and vaccination campaigns. However, there was a decrease in total drug approvals by the FDA, particularly for small molecules. The Biologics class, on the other hand, maintained its figures with the authorization of 15 novel molecules.
Editorial Material
Oncology
Bishal Gyawali, Aaron S. Kesselheim
Summary: The recent approvals of two drugs for metastatic breast cancer suggest that the evidence standards for FDA approval may be decreasing. These drugs not only failed to improve overall survival but also had minimal effects on progression-free survival, delaying progression by only 3 days in one case.
NATURE REVIEWS CLINICAL ONCOLOGY
(2021)
Review
Biochemistry & Molecular Biology
Alexander C. Martins, Mariana Y. Oshiro, Fernando Albericio, Beatriz G. de la Torre, Gustavo Jose Pereira, Rodrigo Gonzaga
Summary: Despite being relatively new, biological drugs have shown great potential and have significantly improved patient survival with fewer adverse reactions. The number of these drugs approved by the FDA has increased in recent years, signaling a promising future for the field.
Review
Pharmacology & Pharmacy
Michael S. Kinch, Zachary Kraft, Tyler Schwartz
Summary: In 2021, the FDA approved 60 new molecular entities (NMEs), reaching the highest level in the post-PDUFA era. Among these NMEs, 49 utilized the incentives of the Orphan Drug Act or obtained approval under Priority, Fast-Track, Accelerated, and/or Breakthrough designations. Although the number of registered clinical trials was lower than the 2020 peak, it remained within the 5-year running average. The rate of industry consolidation and turnover, however, raised concerns about the long-term sustainability of organizations involved in clinical development.
DRUG DISCOVERY TODAY
(2022)
Review
Pharmacology & Pharmacy
Michael S. Kinch, Zachary Kraft, Tyler Schwartz
Summary: The FDA approved a high number of novel molecular entities (NMEs) in 2020, with orphan drug approvals and priority reviews also increasing. Interestingly, the rate of consolidation in the pharmaceutical industry slowed down, leaving a significant number of clinical-stage pharmaceutical companies still active.
DRUG DISCOVERY TODAY
(2021)
Review
Oncology
Shaily Arora, Preeti Narayan, Gwynn Ison, Tara Berman, Daniel L. Suzman, Suparna Wedam, Tatiana M. Prowell, Soma Ghosh, Reena Philip, Christy L. Osgood, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Summary: There has been significant progress in the treatment of gynecologic cancers over the past decade. This article summarizes the FDA approvals for gynecologic cancer treatments from 2010 to 2020, totaling 17 new indications. Six of these indications received accelerated approval, while 11 received regular approval. The approval decisions were supported by primary efficacy endpoints and showed a favorable benefit-risk profile. The article also discusses the current FDA thinking on drug development opportunities and regulatory initiatives.
CLINICAL CANCER RESEARCH
(2022)
Article
Chemistry, Medicinal
Saghir Ali, Jia Zhou
Summary: The objective of this review is to provide an update on fluorine-containing drugs approved by the FDA in the past five years. A total of fifty-eight fluorinated entities were accepted for the diagnosis, mitigation, and treatment of various diseases. The drugs are categorized based on their therapeutic areas and information about their trade name, approval date, active ingredients, developers, indications, and mechanisms of action are provided. This review is expected to inspire drug discovery and medicinal chemistry research in both industrial and academic settings, leading to the discovery of new drugs in the future.
EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY
(2023)
Article
Medicine, General & Internal
Patrick C. DeMartino, Milos D. Miljkovic, Vinay Prasad
Summary: This study aims to estimate the number of eligible cancer patients for newly approved drug-indication pairs and project the potential spending and use in the US. The findings suggest that if all eligible patients use the 2018 FDA-approved oncology drugs, there would be a $39.5 billion increase in cancer drug spending, while using the drugs in fewer than 20% of eligible patients is consistent with industry forecasts for drug spending.
JAMA INTERNAL MEDICINE
(2021)
Article
Oncology
Viktoria Gloy, Andreas M. Schmitt, Pascal Dueblin, Julian Hirt, Cathrin Axfors, Hanna Kuk, Tiago V. Pereira, Clara Locher, Laura Caquelin, Martin Walter-Claudi, Mark P. Lythgoe, Amanda Herbrand, Benjamin Kasenda, Lars G. Hemkens
Summary: We analyzed all cancer drugs approved by the FDA between 2000 and 2020 and found that 49% of drugs were approved without randomized controlled trials, and 82% had only one clinical trial. Although some drugs showed benefits in overall survival, there were limited improvements in quality of life.
INTERNATIONAL JOURNAL OF CANCER
(2023)
Review
Biochemistry & Molecular Biology
Thais Cristina Mendonca Nogueira, Marcus Vinicius Nora de Souza
Summary: In 2020, FDA approved a total of 53 new drugs, with small-molecules accounting for the majority. Oncology was the dominant therapeutic area with 23 new approvals, including 13 new chemical entities.
BIOORGANIC & MEDICINAL CHEMISTRY
(2021)
Review
Pharmacology & Pharmacy
Sonali S. Bharate
Summary: Drugs with poor aqueous solubility can have low and unpredictable oral bioavailability, so it is important to find strategies to enhance solubility. Around half of the new molecular entities approved by the US FDA are pharmaceutical salts, which have been steadily growing since 1939. This review provides updates on 61 pharmaceutical salts approved by the FDA between 2015 and 2019, detailing their chemical structures and therapeutic indications.
DRUG DISCOVERY TODAY
(2021)
Review
Biochemistry & Molecular Biology
Beatriz G. de la Torre, Fernando Albericio
Summary: Similar to last year, 2021 will be remembered for the COVID-19 pandemic. Despite the approval of five vaccines, the pandemic remains uncontrolled. However, there have been significant drug approvals by the FDA, with 50 drugs authorized in 2021. Nitrogen aromatic heterocycles and fluorine atoms continue to be predominant among small molecules.
Review
Biochemistry & Molecular Biology
Beatriz G. de la Torre, Fernando Albericio
Summary: In 2020, a total of 53 new drugs were approved by the US FDA, including 40 new chemical entities and 13 biologics. The approved drugs consist of monoclonal antibodies, antibody-drug conjugates, peptides, and oligonucleotides, with a notable presence of fluorine atoms and/or nitrogen aromatic heterocycles. These new drugs are classified based on their chemical structures as biologics, TIDES, natural products, fluorine-containing molecules, nitrogen aromatic heterocycles, and other small molecules.
Article
Pharmacology & Pharmacy
Ioana Gherghescu, M. Begona Delgado-Charro
Summary: Biosimilar medicines have expanded the biotherapeutic market, with faster development and more approvals in the European market compared to the US market. Adalimumab biosimilars serve as a case study in this research.
Correction
Immunology
Shazia Sheikh, Eliana Biundo, Soizic Courcier, Oliver Damm, Odile Launay, Edith Maes, Camelia Marcos, Sam Matthews, Catherina Meijer, Andrea Poscia, Maarten Postma, Omer Saka, Thomas Szucs, Norman Begg
Article
Public, Environmental & Occupational Health
Patricia R. Blank, Yuki Tomonaga, Thomas D. Szucs, Matthias Schwenkglenks
Article
Pharmacology & Pharmacy
Regina Grossmann, Marcel Andre Schneider, Michael Linecker, Jean-Marie Lehn, Claude Nicolau, Martin Traber, Fabian Tay, Diego Vicente, Alexander Jetter, Annette Mollet, Thomas Szucs, Rolf Graf, Pierre-Alain Clavien, Perparim Limani
PHARMACOLOGICAL RESEARCH
(2020)
Article
Hematology
David Spirk, Tim Sebastian, Martin Banyai, Jurg H. Beer, Lucia Mazzolai, Thomas Baldi, Drahomir Aujesky, Daniel Hayoz, Rolf P. Engelberger, Thomas Kaeslin, Wolfgang Korte, Robert Escher, Marc Husmann, Annette Mollet, Thomas D. Szucs, Nils Kucher
SEMINARS IN THROMBOSIS AND HEMOSTASIS
(2019)
Correction
Biotechnology & Applied Microbiology
P. Leo, Cornelia Leo, Thomas D. Szucs
NATURE REVIEWS DRUG DISCOVERY
(2020)
Article
Multidisciplinary Sciences
Fabienne Witassek, Anne Springer, Luise Adam, Stefanie Aeschbacher, Juerg H. Beer, Steffen Blum, Leo H. Bonati, David Conen, Richard Kobza, Michael Kuehne, Giorgio Moschovitis, Stefan Osswald, Nicolas Rodondi, Christian Sticherling, Thomas Szucs, Matthias Schwenkglenks
Article
Oncology
Chandra P. Leo, Bettina Hentschel, Thomas D. Szucs, Cornelia Leo
Article
Genetics & Heredity
C. Jeiziner, K. Suter, U. Wernli, J. M. Barbarino, L. Gong, M. Whirl-Carrillo, T. E. Klein, T. D. Szucs, K. E. Hersberger, H. E. Meyer zu Schwabedissen
Summary: Implementation of pharmacogenetics and personalized drug therapy aims to prevent adverse drug reactions and treatment failures. Health care professionals rely on drug labels for reliable drug information. However, the current availability of PGx instructions in drug labels is characterized by unstandardized wording, appearance in different sections, and unclear instructions, challenging HCPs to identify, interpret, and apply PGx information effectively.
PHARMACOGENOMICS JOURNAL
(2021)
Article
Cardiac & Cardiovascular Systems
Steffen Blum, Stefanie Aeschbacher, Pascal Meyre, Michael Kuhne, Nicolas Rodondi, Jurg H. Beer, Peter Ammann, Giorgio Moschovitis, Leo H. Bonati, Manuel R. Blum, Peter Kastner, Fiona Baguley, Christian Sticherling, Stefan Osswald, David Conen
Summary: In AF patients, higher levels of IGFBP-7 were strongly associated with CHF hospitalization, and the prognostic information provided by IGFBP-7 was additive to that of NT-proBNP.
Article
Public, Environmental & Occupational Health
Michel Romanens, Ansgar Adams, Isabella Sudano, Waldemar Bojara, Sandor Balint, Walter Warmuth, Thomas D. Szucs
Summary: This study aimed to assess the predictive value of atherosclerosis imaging in individuals aged 40-65, beyond traditional risk calculators. The results indicated that atherosclerosis imaging provided additional prognostic information to conventional risk equations, improving risk assessment for ASCVD in this age group.
PREVENTIVE MEDICINE
(2021)
Article
Multidisciplinary Sciences
Steffen Blum, Stefanie Aeschbacher, Michael Coslovsky, Pascal B. Meyre, Philipp Reddiess, Peter Ammann, Paul Erne, Giorgio Moschovitis, Marcello Di Valentino, Dipen Shah, Juerg Schlaepfer, Rahel Mueller, Juerg H. Beer, Richard Kobza, Leo H. Bonati, Elisavet Moutzouri, Nicolas Rodondi, Christine Meyer-Zuern, Michael Kuehne, Christian Sticherling, Stefan Osswald, David Conen
Summary: This study aimed to investigate the association between types of atrial fibrillation (AF) and adverse outcomes. Through the follow-up of 3843 AF patients, it was found that the type of AF was not associated with the incidence of stroke or systemic embolism.
SCIENTIFIC REPORTS
(2022)
Article
Public, Environmental & Occupational Health
Michel Romanens, Thomas Szucs, Isabella Sudano, Ansgar Adams
PREVENTIVE MEDICINE REPORTS
(2019)
Article
Pharmacology & Pharmacy
Thomas D. Szucs, Kevin P. Szillat, Eva Blozik
PHARMACOGENOMICS & PERSONALIZED MEDICINE
(2018)
