✨It’s amazing what you can achieve working together to advance modern medicine. Recruitment of all 276 patients has been completed in our pivotal phase 2 “ACT” clinical trial of ATX01, as a first in class non opioid treatment for Chemotherapy-Induced Peripheral Neuropathic Pain (#CIPN). We thank all the 41 clinical sites across the USA and Europe, the people and the patients involved in the study that worked hard to meet this important milestone. We eagerly anticipate sharing the potential impact of this treatment for patients battling # NeuropathicPain in Q1 2025. With no specific treatment currently available for #CIPN, our program has secured #FDA fast track development. 🔬Full trial details: https://lnkd.in/ekMN8xjC 📧 contact@algotx.com #Biotech #Pharma #Innovation #Cancer #Oncology
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PCI Pharma Services is collaborating with theranostics specialist ChiRhoClin, Inc. to avoid the potential shortage of a critical diagnostic drug used to test for pancreatic disease and cancer. "ChiRhoStim also supports pancreatic function testing, assists with endoscopic retrograde cholangiopancreatography (ERCP) cannulation, enables gastrinoma testing, and aids in collecting pancreatic fluid for diagnostic purposes." Skip Purich Shawn Cain Read more >> https://lnkd.in/ek5kdc_t #OrphanDrug #DrugDevelopment
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The FDA has updated the label of fluorouracil with more information regarding the risk of severe adverse events for patients with DPD deficiency. Cancer patients with decreased or complete DPD deficiency have an increased risk for toxicity due to their inability to metabolize the main fluoropyrimidine-based chemotherapies. Though the FDA does not yet recommend oncologists test all patients before prescribing these chemotherapies, many institutions nationwide have turned to international organizations like the Clinical Pharmacogenetics Implementation Consortium for guidance and have already implemented pretreatment DPYD testing for cancer patients based on their recommendations. Learn more about the label update and what institutions are doing to lead the way in precision medicine chemotherapy here: https://lnkd.in/gBcA6v3m #pharmacongemonics #FDA #fluorouracil #5FU #precisiononcology #ADEs #ADRs #adversedrugevents #adversedrugreactions
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The FDA has updated the label of fluorouracil with more information regarding the risk of severe adverse events for patients with DPD deficiency. Cancer patients with decreased or complete DPD deficiency have an increased risk for toxicity due to their inability to metabolize the main fluoropyrimidine-based chemotherapies. Though the FDA does not yet recommend oncologists test all patients before prescribing these chemotherapies, many institutions nationwide have turned to international organizations like the Clinical Pharmacogenetics Implementation Consortium for guidance and have already implemented pretreatment DPYD testing for cancer patients based on their recommendations. Learn more about the label update and what institutions are doing to lead the way in precision medicine chemotherapy here: https://lnkd.in/gBcA6v3m #pharmacongemonics #FDA #fluorouracil #5FU #precisiononcology #ADEs #ADRs #adversedrugevents #adversedrugreactions
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Explore the challenges impacting access to and availability of #theranostic #radiopharmaceuticals, including supply and regulatory issues that could influence the availability of these treatments for cancer patients: 👉 https://buff.ly/4bUQhD0 #cancercare #access #radioligandtherapy #radiotheranostics Richard Zimmermann
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In a Phase III MARIPOSA study analysis, amivantamab + lazertinib showed superior mPFS compared to osimertinib in patients with high-risk disease biomarkers like TP53 co-mutations, detectable ctDNA, and baseline brain or liver metastases. It is a hopeful sign for those facing challenge in prognoses. Unlock the Power of Expert Insights and Thorough Analysis with DelveInsight Business Research LLP's ASCO 2024 Exclusive Coverage! https://lnkd.in/g5iXkRUU #ASCO24 #CancerTreatment #ASCO2024 #LungCancer #NSCLC #PharmaInnovation #MedicalResearch #OncologyAdvancements #ClinicalOncology #Pharmaceuticals #HealthcareConference #CancerResearch #ClinicalPractice #MedicalBreakthroughs #CancerCare #PharmaLeaders
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Innovation in cancer therapeutics is driven by the unmet need for prolonged survival. Yet, progression-free survival (PFS), commonly used as a primary endpoint in pivotal clinical trials, and overall survival (OS) are not the two sides of the same coin. According to the present retrospective analysis, less than one-third of FDA indications, approved with immature survival data, showed a statistically significant OS benefit post-authorization. As physicians, we should critically evaluate non-robust clinical evidence in order to optimally inform shared decision making! https://lnkd.in/daS4-ksa #WorthReading
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Alpha Tau Medical Announces Third Quarter 2024 #FinancialResults and Provides Corporate Update - Alpha DaRT® accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the #FDA, to accelerate market access to the Alpha DaRT® for patients with recurrent glioblastoma multiforme (GBM) - - First patient treated in Recurrent Lung Cancer study in Israel, which will assess the safety and feasibility of delivering Alpha DaRT® sources into the lung using an endobronchial ultrasound procedure - - FDA approval of an Investigational Device Exemption (#IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT® - - Cash, cash equivalents & deposits balance of $68.4 million, with runway of at least two years - For the full announcement, please read: https://lnkd.in/dhfve-XC
Alpha Tau Medical Announces Third Quarter 2024 Financial Results and Provides Corporate Update
alphatau.com
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#China #NMPA accepts #Anheart #Therapeutics and #Innovent's second #NDA for #taletrectinib to treat #ROS1-positive #lung #cancer. The Center for Drug Evaluation of China’s National Medical Products Administration has accepted a second New Drug Application for #taletrectinib as a first-line treatment for ROS1-positive non-small cell #lungcancer (#NSCLC). This milestone underscores the potential of taletrectinib as a transformative medicine for patients with advanced or metastatic ROS1-positive NSCLC, supported by positive results from the #TRUST-I trial. #Shantipharmaceuticals
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📰 The pivotal phase 3 INTerpath-009 trial has begun global recruitment, with the first patients now beginning to enroll in Canada, according to an announcement from Merck and Moderna. 📋 The randomized trial is evaluating the investigational individualized neoantigen therapy V940 (mRNA-4157) in combination with pembrolizumab as an adjuvant treatment for patients with resectable Stage II, IIIA, or IIIB NSCLC who did not achieve a pathological complete response after receiving neoadjuvant pembrolizumab plus platinum-based chemotherapy. ➡ Learn more: https://lnkd.in/gRBiJMxD #lcsm #lungcancer
Phase 3 INTerpath-009 Trial of mRNA-4157 Plus Pembrolizumab for NSCLC Begins Recruitment | Docwire News
docwirenews.com
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Merus N.V.' Petosemtamab is emerging as a potential best-in-class option for first-line HNSCC treatment Despite existing standard therapies, HNSCC poses a significant threat with a poor prognosis. Petosemtamab, a human IgG1 bispecific antibody targeting EGFR and LGR5, exhibits ADCC-enhanced activity. Its combination with pembrolizumab is currently under investigation in a Phase II study expansion cohort for 1L HNSCC. Initial findings presented at ASCO reveal clinically meaningful activity and favorable safety, with an impressive overall response rate of 67%. Despite recent strides, HNSCC remains a deadly disease with limited treatment options. However, the synergistic approach of petosemtamab and pembrolizumab shows promise as a potential game-changer, poised to redefine treatment standards for untreated head and neck cancer patients. Benefit from Expert Insights and Extensive Analysis with DelveInsight Business Research LLP's American Society of Clinical Oncology (ASCO) 2024 Exclusive Coverage @ https://lnkd.in/g2i9yJ4D #asco24 #asco #asco2024 #ascoconference #Merus #Petosemtamab #HNSCC #FirstLineTreatment #EGFR #LGR5 #BispecificAntibody #ClinicalTrials #ASCO #Immunotherapy #CancerTreatment #ClinicalResearch #MedicalInnovation #CancerTherapy
Petosemtamab for HNSCC Treatment | ASCO 2024
delveinsight.com
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