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  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    Review, Journal:  Antibody - Drug Conjugates as a Novel Therapeutic Modality to Treat Recurrent Refractory Germ Cell Tumors. (Pubmed Central) -  Jun 24, 2024   
    ADCs are a novel type of targeted antitumor agents that combine tumor antigen-specific monoclonal antibodies with chemically linked chemotherapeutic drug (payload) exerting a cytotoxic effect. Several FDA - approved ADCs use as targeting moieties the antigens that are also detected in the GCTs, offering a benefit of this type of the targeted therapy even for refractory relapsing TGCT patients unresponsive to standard chemotherapy.
  • ||||||||||  Fetroja (cefiderocol) / Shionogi
    Preclinical, Journal:  In vitro activity of cefiderocol against European Enterobacterales, including isolates resistant to meropenem and recent?-lactam/?-lactamase inhibitor combinations. (Pubmed Central) -  Jun 21, 2024   
    Cefiderocol susceptibility was higher than approved ?-lactam/?-lactamase inhibitor combinations and largely comparable to cefepime-taniborbactam and aztreonam-avibactam against all Enterobacterales (98.1% vs 78.1%-?97.4% and 98.7%-99.1%, respectively) and Enterobacterales resistant to meropenem (n = 148, including 125 Klebsiella spp.; 87.8% vs 0%-71.6% and 93.2%-98.6%, respectively), ?-lactam/?-lactamase inhibitor combinations (66.7%-?92.1% vs 0%-?88.1% and 66.7%-97.9%, respectively), and to both meropenem and ?-?lactam/?-lactamase inhibitor combinations (61.9%-65.9% vs 0%-?20.5% and 76.2%-97.7%, respectively)...Early susceptibility testing of cefiderocol in parallel with ?-lactam/?-lactamase inhibitor combinations will allow patients to receive the most appropriate treatment option(s) available in a timely manner. This is particularly important when options are more limited, such as against metallo-?-lactamase-producing Enterobacterales.
  • ||||||||||  Kadcyla (ado-trastuzumab emtansine) / Roche, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Review, Journal:  Use of Antibody-Drug Conjugates in the Early Setting of Breast Cancer. (Pubmed Central) -  Jun 19, 2024   
    Ado-trastuzumab emtansine is presently the only approved ADC for the treatment of breast cancer in the early setting, while several ADCs are now approved for metastatic breast cancer...Efforts are provided in ongoing clinical trials to identify the patients who will benefit most, to pursue paradigms of precision medicine with the novel ADCs. This review focuses on the potential role of ADCs in early breast cancer, providing an overview of the latest progress in their development and how they are implemented in ongoing clinical trials.
  • ||||||||||  Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
    Preclinical, Review, Journal, Real-world evidence, Real-world:  Eravacycline: a comprehensive review of in vitro activity, clinical efficacy, and real-world applications. (Pubmed Central) -  Jun 16, 2024   
    Despite common gastrointestinal adverse events, eravacycline maintains an overall favorable safety profile, reinforcing its status as a tolerable antibiotic. However, ongoing research is essential for refining eravacycline's role, exploring combination therapy, and assessing its performance against biofilms, contributing to its continued success in combating challenging bacterial infections.
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    Retrospective data, Review, Journal, Metastases:  Sacituzumab govitecan vs. chemotherapy for metastatic breast cancer: a meta-analysis on safety outcomes. (Pubmed Central) -  Jun 12, 2024   
    No statistically significant differences were reported in terms of grade 3-4 fatigue, all grade nausea, febrile neutropenia and treatment discontinuation due to adverse events. Our data, coupled with a statistically and clinically meaningful survival benefit, support the use of SG for mBC.
  • ||||||||||  Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
    New P4 trial:  TheraCRAB: Therapeutic Options for CRAB (clinicaltrials.gov) -  Jun 2, 2024   
    P4,  N=108, Not yet recruiting, 
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Enrollment open, Metastases:  SERIES: Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC (clinicaltrials.gov) -  May 31, 2024   
    P2,  N=75, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Review, Journal:  Current Status and Future Perspectives of Antibody-Drug Conjugates in Hormone Receptor-Positive Breast Cancer. (Pubmed Central) -  May 25, 2024   
    ADCs typically consist of a cytotoxic payload attached by a linker to a monoclonal antibody that targets a specific tumor-associated antigen, offering the advantage of a more selective delivery of chemotherapy to cancer cells. In this review, we focus on the ADC mechanisms of action, their toxicity profile and therapeutic uses as well as on related biomarkers and future perspectives in advanced HR+ breast cancer.
  • ||||||||||  Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva, Zemdri (plazomicin) / Ionis, Achaogen
    Review, Journal:  Multi-resistant organisms in burn patients: an end or a new beginning. (Pubmed Central) -  May 23, 2024   
    Accurate and rapid diagnostic and monitoring tools for detecting MDROs in burn patients should be developed. The emergence of MDROs in burn care is a challenge and a new beginning in infection innovation and novel treatments.
  • ||||||||||  Biomarker, Enrollment closed:  Strata PATH (clinicaltrials.gov) -  May 21, 2024   
    P2,  N=700, Active, not recruiting, 
    This decision was made for efficacy reasons only and is not due to any safety concerns. Recruiting --> Active, not recruiting
  • ||||||||||  Retrospective data, Journal, Gram negative:  Assessing Clinician Utilization of Next-Generation Antibiotics Against Resistant Gram-Negative Infections in U.S. Hospitals : A Retrospective Cohort Study. (Pubmed Central) -  May 20, 2024   
    To determine use patterns of recently U.S. Food and Drug Administration (FDA)-approved gram-negative antibiotics (ceftazidime-avibactam, ceftolozane-tazobactam, meropenem-vaborbactam, plazomicin, eravacycline, imipenem-relebactam-cilastatin, and cefiderocol) and identify factors associated with their preferential use (over traditional generic agents) in patients with gram-negative infections due to pathogens displaying difficult-to-treat resistance (DTR; that is, resistance to all first-line antibiotics)...Patients were treated exclusively using traditional agents in 1091 of 2631 DTR episodes (41.5%), including "reserve" antibiotics such as polymyxins, aminoglycosides, and tigecycline in 865 of 1091 episodes (79.3%)...U.S. Food and Drug Administration; NIH Intramural Research Program.
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    Review, Journal, IO biomarker:  Types and progress of clinical trial design for breast cancer: a narrative review. (Pubmed Central) -  May 16, 2024   
    (II) Addressing research breadth, "master protocols" such as basket trials (IMMU-132-01), umbrella trials (FUTURE), and platform trials (I-SPY 2) have been introduced, allowing the simultaneous assessment of multiple treatments or disease subtypes within a singular framework...Clinical trial design in breast cancer research has been revolutionized, moving towards more efficient and targeted strategies. Despite the presence of ethical, logistical, and data complexities, it is anticipated that ongoing technological and regulatory enhancements will pave the way for even more refined research approaches, subsequently influencing future research, clinical practices, and policymaking in breast cancer care.
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    P3 data, Journal, Metastases:  Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. (Pubmed Central) -  May 15, 2024   
    Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Sacituzumab govitecan (SG), a first-in-class anti-trophoblast cell surface antigen 2 (Trop-2) antibody-drug conjugate, demonstrated superior efficacy over single-agent chemotherapy (treatment of physician's choice [TPC]) in patients with metastatic triple-negative breast cancer (mTNBC) in the international, multicenter, phase III ASCENT study.Patients were randomly assigned 1:1 to receive SG or TPC until unacceptable toxicity/progression...Overall, SG had a manageable safety profile, with ?5% of treatment-related discontinuations because of adverse events and no treatment-related deaths. The safety profile was consistent across all subgroups.These data confirm the clinical benefit of SG over chemotherapy, reinforcing SG as an effective treatment option in patients with mTNBC in the second line or later.
  • ||||||||||  Review, Journal:  Managing Risks with Newer Oral Small Molecules in Patients with Inflammatory Bowel Diseases. (Pubmed Central) -  May 9, 2024   
    Ozanimod and etrasimod, S1PR agonists, require closer safety profile monitoring by clinicians...However, they have been associated with AEs, and some require close monitoring prior to and during therapy. Clinicians should highlight these adverse events to patients while reassuring the safety profile of these novel SMDs for IBD is favorable.
  • ||||||||||  IDE397 / Ideaya Biosci
    Enrollment change, Trial completion date, Trial primary completion date, Metastases:  IDE397-001: Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion (clinicaltrials.gov) -  May 7, 2024   
    P1,  N=180, Recruiting, 
    These combination therapies present promising new options for the treatment of CRKP infection. N=130 --> 180 | Trial completion date: Jun 2024 --> Mar 2027 | Trial primary completion date: Dec 2023 --> Dec 2026