The BLA seeking approval for remestemcel-L for children with steroid-refractory acute graft-vs-host-disease has been resubmitted to the FDA. #oncology https://lnkd.in/eifn5PSk
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Learn more about our upcoming IFx-2.0 Phase 3 registration trial under accelerated approval here: https://bit.ly/3wgGpV5 #BifunctionalADC #CancerVaccine #TumorMicroenvironment #Oncology
IFX-2.0: Phase 3 Registration Trial - TuHURA
https://tuhurabio.com
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The lutetium Lu 177 vipivotide tetraxetan shortage appears to be finally over, which is great news for patients. The discovery of PSMA directed therapy and PSMA PET scans has really changed the way we treat prostate cancer after progression. While this therapy is limited to PSMA positive patients, lutetium Lu 177 vipivotide tetraxetan showed an overall survival benefit in an area where patients have limited or no options. It also is a little frustrating that Novartis can double their production within 5 months, but some of these other chemotherapy agents seem to be on shortage for years. #prostatecancer #pluvicto https://lnkd.in/gpRb_MzH
Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers
novartis.com
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Discover how the FDA's groundbreaking projects, Optimus and FrontRunner, could impact your oncology journey in our insightful blog. Whether it's preparing for agency meetings or fine-tuning clinical trial designs, our scalable support empowers you to accelerate development outcomes and elevate your product's potential. Read the blog now: https://lnkd.in/eiv6MGY5 #HealthcareAdvisors #RegulatoryAffairs #Oncology #QualityAssurance
The impact of FDA’s Project Optimus and Project FrontRunner
gandlhealth.com
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A very interesting study was just published in JAMA. I'm just going to leave the authors conclusions here: Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within 5 years of accelerated approval. Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes. #fda #oncology #approvals #acceleratedapproval #efficacy #qualityoflife
Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval
jamanetwork.com
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Just two months after earning another approval for its blockbuster blood cancer drug #Breyanzi, Bristol Myers Squibb can add an accelerated approval to the list, this time in the third-line setting for adult patients with relapsed or refractory follicular lymphoma. The FDA approved the single-dose, one-time CAR-T therapy for the indication based on response rate and duration of response in the TRANSCEND-FL trial — the overall response rate was 95.7% while the complete response rate was 73.4%. Bristol Myers said the responses were “rapid and durable,” with 80.9% still responding at 12 months, and 77.1% responding at 18 months.... #Approval #FDA #celltherapy #cellandgenetherapy #advancedtherapies #pharma #pharmaceuticals #therapeutics #cancer #oncology #lungcancer #carttherapies #tcells #acceleratedapproval #bloodcancer #lymphoma #lifesciences #biotech #biotechnology #patientaccess
Bristol Myers wins accelerated approval for another blood cancer for blockbuster Breyanzi
https://endpts.com
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🌟 Big strides in melanoma treatment! 🌟 The FDA has given the green light to Opdivo® (nivolumab) by Bristol Myers Squibb as an adjuvant treatment for certain melanoma stages. This approval, backed by the Phase 3 CheckMate -76K trial, reveals that Opdivo substantially decreases the risk of recurrence or death by a significant 58% compared to a placebo. 🔍 This is monumental for patients post-surgery, as a notable number unfortunately see their melanoma return within five years. Dr. John M. Kirkwood from UPMC Hillman Cancer Center emphasized the importance of this advancement for melanoma patients. 🩺 Dive deeper into the details with the full article below! ⬇️ #FDAApproval #MelanomaTreatment #Opdivo #BristolMyersSquibb #CheckMate76K #OncologyNews #MedicalAdvancements #CancerResearch #PatientCare #BreakthroughTherapy https://lnkd.in/gQMqKgaS
U.S. Food and Drug Administration Approves Opdivo®(nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma1
news.bms.com
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5 ways to increase the value of your oncology drug spend. 1. Use a medically integrated pharmacy for dispensing oncology medications 2. Conduct INDEPENDENT evaluations of the clinical evidence of oncology drugs as part of your reimbursement decision-making process 3. Implement guideline-based care 4. Institute value-based drug pricing 5. Mandate switching to biosimilars whenever possible #valuebasedcare #oncology #biosimilars
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Prostate cancer continues to be a significant health concern for men worldwide. However, recent advancements in medical technology are poised to revolutionize how this disease is treated. One such innovation is using pre-filled syringes for targeted radiopharmaceutical therapies, offering new hope and improved outcomes for patients battling prostate cancer. Learn more: https://lnkd.in/dQGitAGu #PreFilledSyringes #MedicalDevices #InjectionSafety #Pharmaceuticals #DrugDelivery #HealthcareTech #MedicationManagement #PatientSafety #NeedleSafety #InnovativeMedicine #HealthTech #MedicationAdministration #SyringeTechnology #PrecisionMedicine #InnovationInHealthcare #MedicationCompliance #HealthcareSolutions #TherapeuticOptions #DrugDosage #HealthcareAdvancements
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Important work being presented here at #AACR: improvement in a RECIST-based surrogate endpoint like PFS or ORR does not consistently translate into OS benefit. This is why FDA is beginning to request higher quality evidence from clinical trial sponsors. The Accelerated Approval pathway is important, and there is a clear need for surrogates that are clinically meaningful.
About half of cancer drugs approved via accelerated approval fail to improve patient survival or quality of life in subsequent clinical trials, according to data presented at AACR. https://trib.al/P9fZFaF
About half of cancer drugs given accelerated approval don’t improve survival or quality of life
https://www.statnews.com
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Hassling Pharma to recognize limits to therapy of advanced cancer. Steering towards diagnostics and early detection, then maybe therapy. Surgeons are the key.
How hyping up drugs can damage patients: The Impact of Exuberance on Equipoise in Oncology Clinical Trials: Sotorasib as Archetype https://lnkd.in/enku32M5
The Impact of Exuberance on Equipoise in Oncology Clinical Trials: Sotorasib as Archetype
academic.oup.com
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