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FDA Mandates New CAR T-Cell Therapy Boxed Warnings in Hematologic Cancers The FDA has required updated boxed warnings for secondary T-cell malignancy risks in patients who receive CAR T-cell immunotherapies targeting BCMA or CD19, according to a press release from the regulatory agency. The agency previously issued a safety communication to highlight reports of secondary T-cell malignancies following treatment with the aforementioned T-cell therapies in November 2023.2 At the time of the press release, the FDA noted that the benefits outweighed the potential risks of these treatments. According to the agency, the risk of T-cell malignancies extended to all currently approved products in this drug class, which included the following agents: Idecabtagene vicleucel (ide-cel; Abecma) Lisocabtagene maraleucel (liso-cel; Breyanzi) Ciltacabtagene autoleucel (cilta-cel; Carvykti) Tisagenlecleucel (tisa-cel; Kymriah) Brexucabtagene autoleucel (Tecartus) Axicabtagene ciloleucel (axi-cel; Yescarta) https://lnkd.in/eFEsNc7Z

WHAT IS AN LVAD?   Cadrenal Therapeutics intends to conduct pivotal clinical trials in newly implanted LVAD patients for its oral anticoagulant candidate tecarfarin to show its superiority to warfarin. A left ventricular assist device (LVAD) is a circulatory assist device implanted in patients with advanced heart failure or awaiting a heart transplant. Patients with LVADs require chronic anticoagulation to reduce the risk of bleeding and thromboembolic complications, which are common in these patients.    Anticoagulation management for individuals with LVADs continues to be a challenge. Warfarin is not FDA-approved for LVAD patients and is used off-label for this population with sub-optimal results. A meta-analysis found that LVAD patients are in the proper Time in Therapeutic Range (TTR) only 46.6% of the time (*), despite the desired range of 60% or more. This suggests that warfarin is difficult to manage in LVAD patients, which may contribute to high rates of adverse events (*). Warfarin is known for its wide range of drug interactions as well as metabolism challenges due to concomitant end-stage renal disease common in LVAD patients.   A Cadrenal Therapeutics key goal is to bring tecarfarin to market as a new oral anticoagulation solution to fill this critical unmet LVAD patient need. Recognizing this need, the FDA recently granted tecarfarin with an Orphan Drug Designation for LVAD patients. (*) Meta-Analysis of Time in Therapeutic Range in Continuous-Flow Left Ventricular Assist Device Patients Receiving Warfarin Brandon K Martinez et al. Artif Organs. 2018 Jul. #cadrenal #nasdaq #lvad #heartfailure #anticoagulation

The pace of change in pharmacy – from medical breakthroughs to regulatory battles – is overwhelming. Navigating the ever-changing landscape of pharmacy benefit management can be overwhelming. Discover how to tackle the challenges posed by GLP-1 medications, ultra-high-cost therapeutics, and targeted cancer treatments in 2024 and beyond. #employeebenefits #glp1 #genetherapy #pharmacybenefits #costcontainment #marshmma

In a significant development in #anticoagulation therapy, Anthos Therapeutics' #BloodThinner #abelacimab has demonstrated promising results by reducing #bleeding risks in patients with #atrialfibrillation by 67%. Presented at the American Heart Association's #AHA2023 meeting, this novel treatment has outperformed the widely used blood thinner, #Xarelto, in a pivotal study, bringing new hope for safer anticoagulant options. “With a substantial 67% lower risk of bleeding for the combined primary endpoint of major or clinically relevant non-major bleeding, these ground-breaking results not only support the superior safety of abelacimab as compared with a commonly used DOAC, but also strongly supports the promise of Factor XI inhibition as a paradigm-shifting treatment approach,” said Christian Ruff, MD, MPH, Principal Investigator, AZALEA-TIMI 71. https://lnkd.in/etxY5DK4

The BruLoop study involved 370 patients with Brugada syndrome from 18 international centers, monitored for 3 years with an implantable loop recorder (ILR). The main results include that 25.4% of patients experienced an arrhythmic event, with 16% having an atrial arrhythmia, 5% a ventricular arrhythmia, and 8% a bradyarrhythmia. 8.6% of patients had arrhythmic syncope. The induction of ventricular fibrillation during an electrophysiological study emerged as the only predictor of ventricular arrhythmias. Clinical implications include that 18.4% of patients reached a composite endpoint, with 6.2% receiving an ICD implant and 2.2% a pacemaker. Drug therapy was initiated in 9.0% of patients. Statistical analysis was conducted using SPSS 23.0, with statistical significance set at p < 0.05. Data were presented as mean ± standard deviation or median and interquartile range depending on the distribution. Differences between groups were assessed using parametric or non-parametric tests, while survival analysis was performed using the Kaplan-Meier method. Regression analysis was used to identify independent predictors of ventricular arrhythmias. In summary, the BruLoop study provides important information on the incidence and clinical implications of arrhythmic events in patients with Brugada syndrome, emphasizing the importance of continuous monitoring with ILR and early detection of potential arrhythmias to improve the management of this condition. https://lnkd.in/egfSA_8Y

Becoming an Oncology Clinical Pharmacist ▶️In the chemotherapy ward,two patients received different doses of a drug,each dispensed with different brands by the pharmacist as indented.A spillage occured during compounding,promoting the pharmacist to use leftover medication from another patient to complete the dose.One of the patients experienced a reaction upon administration,which was not typical for them.Upon investigation,it was discovered by a fellow pharmacist that different brands were used to fill the dose, potentially explaining the unexpected reaction. 🧑🔬Compatibility of drugs need to be checked before compounding and is very crucial during preparation to ensure the efficacy, safety,and stability of medications used in cancer treatment. 👉Are you 🙋 interested in knowing more about compatibilities of drugs in oncology 📒 Information is available on the web and is it enough to practice.Its all about experience. 💡Do u think🤔training for pharmacists is required to practice in speciality setting for quality care of the patients. 📢Stay tuned if you want to learn oncology and transform yourself into an oncology clinical pharmacist

👨🏻⚕️💊Oncology Supportive Care👨🏻⚕️💊 🔴🔴Extravasation Injuries 🔴🔴 1. A vesicant is an agent that, on extravasation, can cause tissue necrosis. Vesicant antineoplastic drugs include doxorubicin, daunorubicin, epirubicin, mechlorethamine, mitomycin, vincristine, vinblastine, vinorelbine, and streptozocin. 2. Anthracyclines cause the most severe tissue damage on extravasation.❗️ 3. The literature generally recommends administering vesicants by parenteral injection rather than infu-msion, but some exceptions exist. a. Some institutional policies require infusions for every drug or approved protocols. b. Vincristine has been incorrectly administered by intrathecal injection, with fatal consequences. Dilution of vincristine for administration as a short parenteral infusion has been recommended to prevent this error from occurring. c. Paclitaxel (an irritant with vesicant-like properties) is administered as an infusion (1, 3, or 24 hours, depending on the protocol). 4. Management of extravasation a- Cold for doxorubcin, daunorubicin, and epirubicin. b-Heat for vincristine, vinblastine, and vinerolbine, c- Topical Dimethyl sulfoxide has been recommended for anthracycline. e- Dexrazoxane for doxorubicin, daunorubicin, epirubicin, and idarubicin. Cold compress should be removed 15 minutes before dexrazoxane treatment. 🔴Always Remember That #Medicines may #cure but Only #pharmacists can Care. #pharmacy #oncology #extravasation #hospital #emergency

Foresee Pharmaceuticals is pleased to announce the positive safety review by the independent Data and Safety Monitoring Board (DSMB) for its Casppian Phase 3 registration study. The DSMB recommended the continuation of patient enrollment as planned. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of Leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). Foresee’s Leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer.   There has been no safety concern with the use of Leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. Learn more👉https://lnkd.in/gbpG-t5C #leuprolide #leuprorelin #readytouse #CentralPrecociousPuberty #Casppian

Antiplatelets vs. Anticoagulants: A Comparative Study in Cervical Artery Dissection A recent study analyzed the effectiveness and risks of antiplatelet and anticoagulant therapies for cervical artery dissection. The study included 11 studies with a total of 5039 patients. Anticoagulation therapy was found to be more effective in reducing the risk of ischemic stroke but had a higher risk of major bleeding compared to antiplatelet therapy. The risks of death and symptomatic intracranial hemorrhage were similar between the two treatments. The study suggests the need for more research and large, randomized clinical trials to determine the best treatment approach for cervical artery dissection. For more details please click the link! https://lnkd.in/dvdhnTcF #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

D-VRd Treatment Regimen Demonstrates Better Progression-Free Survival Among Transplantation-Eligible Patients With Multiple Myeloma: In addition to improved progression-free survival, patients treated with this regimen also showed improved complete response or stronger and were minimal residual disease-negative. #finance #pharmacy #lifesciences