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  • ||||||||||  Journal:  PAPA Syndrome: Challenges in Achieving Long-Term Remission. (Pubmed Central) -  Nov 30, 2023   
    inhibitors, such as adalimumab, etanercept, and infliximab, have been generally regarded as a more effective treatment option for cutaneous changes, while anakinra, an anti-IL-1 agent, has been more beneficial in alleviating joint symptoms (9-11)...Furthermore, the available therapeutic options are not sufficient to achieve long-term remission in many patients. Thus, continuous and comprehensive research is vital for ensuring adequate care of patients with PAPA syndrome.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Journal:  Use of darbepoetin alfa in haemolytic disease of the fetus and newborn. (Pubmed Central) -  Nov 30, 2023   
    Treatment with darbepoetin alfa or other types of erythropoietin should be considered as part of the postnatal treatment of severe haemolytic disease of the fetus and newborn. No abstract available
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Journal:  Osteonecrosis of the jaw under palbociclib: A case series description. (Pubmed Central) -  Nov 30, 2023   
    The optimal sequence of therapies post CDK4/6 inhibitors remains unknown but rechallenge with an alternative agent is possible. We did not identify a specific pattern that could suggest a triggering role of palbociclib in the development of ONJ.
  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
    Preclinical, Review, Journal:  Integration of signaling pathway and bromodomain and extra-terminal domain inhibition for the treatment of mutant Kirsten rat sarcoma viral oncogene homolog cancer. (Pubmed Central) -  Nov 30, 2023   
    Unfortunately, progression-free survival (PFS) of lung cancer patients is only 5-6 months and no survival advantage has been found for sotorasib in comparison to docetaxel chemotherapy...Such enhancers can be targeted by bromodomain and extra-terminal (BET) inhibitors (BETi) or degraders and this review discusses whether integrated SOS1 inhibition and BET targeting of MYC synergizes against mutant KRAS tumor growth. BET degraders in the form of proteolysis-targeting chimeras (PROTACs) combined with BAY-293-mediated SOS1 inhibition revealed marked cytotoxic synergy against mutant KRAS cancer cells and may constitute a promising option for clinical treatment.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Trial completion date, Trial primary completion date, Combination therapy:  AALL1731: A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (clinicaltrials.gov) -  Nov 30, 2023   
    P3,  N=6720, Recruiting, 
    BET degraders in the form of proteolysis-targeting chimeras (PROTACs) combined with BAY-293-mediated SOS1 inhibition revealed marked cytotoxic synergy against mutant KRAS cancer cells and may constitute a promising option for clinical treatment. Trial completion date: Mar 2030 --> Jun 2029 | Trial primary completion date: Mar 2030 --> Jun 2029
  • ||||||||||  Enrollment status, Trial completion date, Trial primary completion date:  FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) -  Nov 30, 2023   
    P4,  N=148, Enrolling by invitation, 
    Phase classification: P1b/2 --> P1/2 Recruiting --> Enrolling by invitation | Trial completion date: Jun 2023 --> Mar 2025 | Trial primary completion date: Jun 2023 --> Mar 2025
  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
    Journal:  A Nexus between Genetic and Non-Genetic Mechanisms Guides KRAS Inhibitor Resistance in Lung Cancer. (Pubmed Central) -  Nov 29, 2023   
    Thus, in response to drug treatment, reversible drug-tolerant phenotypes emerge via non-genetic mechanisms that eventually enable the emergence of irreversible resistant clones via genetic mutations. Furthermore, we also discuss the recent data demonstrating how combination therapy can help alleviate KRAS drug resistance in lung cancer, and how new treatment strategies based on evolutionary principles may help minimize or even preclude the emergence of drug resistance.
  • ||||||||||  Review, Journal:  Unanswered questions on the use of biologics in pediatric asthma. (Pubmed Central) -  Nov 29, 2023   
    Since the launch of omalizumab, several other biologics have been marketed or are close to being marketed, suggesting that a plethora of monoclonal antibodies can be expected in the coming years...For these reasons, along with the relatively short time of use with these treatments, there are recurrently arising questions for which there are not even moderately documented answers, and for which the only solution must be based, with all reservations, on the combination of indirect evidence and expertise. In this paper, we attempt to address such questions, providing relevant commentaries and considering the whole width of the evidence base.
  • ||||||||||  Journal:  Aneurysm and Artery Dissection After Oral VEGFR-TKI Use in Adults With Cancer. (Pubmed Central) -  Nov 29, 2023   
    In this study, the use of oral VEGFR-TKIs was associated with an increased risk of AAD occurrence. These findings elucidate vascular toxic effects and may provide a substantial reference for reducing the socioeconomic burden of adverse events associated with VEGFR-TKI use.
  • ||||||||||  ATI-2231 / Aclaris
    Enrollment change, Trial withdrawal:  ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Nov 29, 2023   
    P1,  N=0, Withdrawn, 
    Initiation date: Sep 2023 --> May 2024 N=36 --> 0 | Suspended --> Withdrawn
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    New trial:  Aimovig Pregnancy Exposure Registry (clinicaltrials.gov) -  Nov 29, 2023   
    P=N/A,  N=2842, Recruiting, 
  • ||||||||||  Nplate (romiplostim) / Amgen, Kyowa Kirin, Promacta (eltrombopag) / Novartis
    Journal:  Treatment of immune thrombocytopenia during pregnancy with thrombopoietin receptor agonists. (Pubmed Central) -  Nov 29, 2023   
    This review suggests that the use of TPO-RA during pregnancy is associated with a high response rate and appears safe. Nevertheless, TPO-RA should not be routinely used in pregnancy and should be avoided in the first trimester until further evidence is accumulated.
  • ||||||||||  Recentin (cediranib) / AstraZeneca
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (clinicaltrials.gov) -  Nov 29, 2023   
    P2,  N=34, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Nov 2023
  • ||||||||||  zelminemab (AMG 301) / Amgen, Novartis, Lu AG09222 / Lundbeck
    Review, Journal:  From CGRP to PACAP, VIP, and Beyond: Unraveling the Next Chapters in Migraine Treatment. (Pubmed Central) -  Nov 28, 2023   
    In light of recent advances in PACAP research, we emphasize the potential of PACAP as a promising target for migraine treatment, highlighting the significance of exploring PACAP as a member of the antimigraine armamentarium, especially for patients who do not respond to or contraindicated to anti-CGRP therapies. By updating our knowledge of PACAP and its unique contribution to migraine pathophysiology, we can pave the way for reinforcing PACAP and other secretin peptides, including VIP, as a novel treatment option for migraines.
  • ||||||||||  Review, Journal:  Management of Brain Metastases: A Review of Novel Therapies. (Pubmed Central) -  Nov 28, 2023   
    Novel systemic therapies with intracranial utility include new anaplastic lymphoma kinase inhibitors like brigatinib and ensartinib; selective "rearranged during transfection" inhibitors like selpercatinib and pralsetinib; B-raf proto-oncogene inhibitors like encorafenib and vemurafenib; Kirsten rat sarcoma viral oncogene inhibitors like sotorasib and adagrasib; ROS1 gene rearrangement (ROS1) inhibitors, anti-neurotrophic tyrosine receptor kinase agents like larotrectinib and entrectinib; anti-human epidermal growth factor receptor 2/epidermal growth factor receptor exon 20 agent like poziotinib; and antibody-drug conjugates like trastuzumab-emtansine and trastuzumab-deruxtecan. This review highlights the modern multidisciplinary management of BM, emphasizing the integration of systemic and local therapies.
  • ||||||||||  PK/PD data, Review, Journal:  Pharmacokinetic considerations for angiogenesis inhibitors used to treat hepatocellular carcinoma: an overview. (Pubmed Central) -  Nov 28, 2023   
    Anti-angiogenic drugs have different profiles in terms of bioavailability, metabolism, elimination and interindividual variability in their pharmacokinetics and effectiveness. More studies should be developed to address the intrinsic and extrinsic factors influencing pharmacokinetics parameters to improve the individual therapeutic response and, furthermore, to evaluate the benefit and the harm of systemic therapy for advanced HCC in selected patients with liver impairment.
  • ||||||||||  Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
    Journal, PARP Biomarker, PD(L)-1 Biomarker:  Molecular-based targeted therapies in patients with hepatocellular carcinoma and hepato-cholangiocarcinoma refractory to atezolizumab/bevacizumab. (Pubmed Central) -  Nov 28, 2023   
    More studies should be developed to address the intrinsic and extrinsic factors influencing pharmacokinetics parameters to improve the individual therapeutic response and, furthermore, to evaluate the benefit and the harm of systemic therapy for advanced HCC in selected patients with liver impairment. Molecular-based guided therapy is feasible in patients with HCC/H-CCK progressing under atezolizumab/bevacizumab and may be useful in a small subset of patients.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    PK/PD data, Journal:  Evaluating the Pharmacokinetics and Pharmacodynamics of Chemotherapeutics within a Spatial SILAC-Labeled Spheroid Model System. (Pubmed Central) -  Nov 28, 2023   
    Using pulsed isotopic labels, we demonstrate the pronounced differential response of the proteome to the drug Regorafenib, a multikinase inhibitor, in HCT 116 spheroids...Thus, pulsed isotopic labeling enables evaluation of the distinct proteomic responses for cells residing in the different chemical microenvironments of the spheroid. This platform promises great utility in assisting researchers' predictions of pharmacodynamic therapeutic responses within complex tumors.
  • ||||||||||  lisaftoclax (APG-2575) / Ascentage Pharma
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer (clinicaltrials.gov) -  Nov 28, 2023   
    P1/2,  N=65, Recruiting, 
    This platform promises great utility in assisting researchers' predictions of pharmacodynamic therapeutic responses within complex tumors. Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
  • ||||||||||  Scemblix (asciminib) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
    Trial completion date, Trial primary completion date:  ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML (clinicaltrials.gov) -  Nov 28, 2023   
    P1,  N=40, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2025
  • ||||||||||  Nailike (olverembatinib) / Ascentage Pharma, Takeda
    Trial primary completion date:  HQP1351CU101: Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL (clinicaltrials.gov) -  Nov 27, 2023   
    P1,  N=62, Recruiting, 
    Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2025 Trial primary completion date: Jan 2023 --> Jan 2024