NCCN

Veracyte’s Decipher Prostate Test Receives Highest Evidence-Level Rating Among Molecular Tests in Updated Prostate Cancer NCCN Guidelines

Retrieved on: 
Dienstag, Februar 27, 2024
Software, Research, Professional Services, Oncology, Biometrics, Technology, Medical Devices, Artificial Intelligence, Health Technology, Data Analytics, Science, Biotechnology, Health, Clinical trial, Risk, Disease, Prostate, Criterion, Biomarker, NCCN, Classification, Prostate cancer, Patient, 1B, Medical imaging

(Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its Decipher Prostate Genomic Classifier is the only gene expression test to receive a “Level 1B” evidence rating in the 2024 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a prognostic tool for the risk stratification of patients with localized prostate cancer.

Key Points: 
  • (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its Decipher Prostate Genomic Classifier is the only gene expression test to receive a “Level 1B” evidence rating in the 2024 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a prognostic tool for the risk stratification of patients with localized prostate cancer.
  • Level 1B was assigned to Decipher Prostate based on the evidence in both the post-biopsy and post-prostatectomy settings.
  • Additionally, because of this classification, the Decipher Prostate test is the only gene expression test for which the guidelines synthesize the available published data in a separate table that summarizes treatment implications for patients based on both their NCCN risk classification and Decipher score.
  • They summarize the treatment implications for patients based on their Decipher score and the published evidence from analyses of multiple randomized, phase 3 clinical trials.

Veracyte Announces Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Donnerstag, Februar 22, 2024
Software, Internet, Oncology, Health, Artificial Intelligence, Data Management, Health Technology, Technology, Acquisition, Endocrinology, Prostate cancer, Investment, 2005 in television, Table, NGS, GAAP, Level 1, TERT, NCCN, Webcast, Abstract, Patient, MRD, Prostate, Publication, Genomics, IVD, Video game

Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.
  • “We closed 2023 with another quarter of excellent results, driven by our Afirma and Decipher businesses,” said Marc Stapley, Veracyte’s chief executive officer.
  • Total revenue for the fourth quarter of 2023 was $98.2 million, an increase of 22% compared to $80.3 million reported in the fourth quarter of 2022.
  • Total gross margin for the fourth quarter of 2023, including the amortization of acquired intangible assets, was 66%, compared to 61% in the fourth quarter of 2022.

NCCN Updates Treatment Recommendations for Breast, Colorectal, Lung, and other Cancer Types Based on Emerging Evidence

Retrieved on: 
Montag, März 4, 2024
Classification, Neoplasm, MD, System, Heredity, Bladder cancer, Lung, Principle, Conference, Breast, Lung cancer, Kidney cancer, NCCN, Pathology, Patient, Virtual, National Comprehensive Cancer Network, Medicine, Poster, Research, Medical imaging

PLYMOUTH MEETING, Pa., March 4, 2024 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) is announcing several new updates to the cancer treatment practices listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). The evidence-based expert consensus recommendations are the most frequently updated guidelines for any area of medicine and are used by cancer care providers worldwide to stay up to date on innovations. Recently, the alliance of leading cancer centers published updated versions for several high-incidence cancer types, including breast, colorectal, lung, and pancreatic.

Key Points: 
  • Latest recommendations and underlying evidence will be explained at NCCN 2024 Annual Conference April 5-7.
  • PLYMOUTH MEETING, Pa., March 4, 2024 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) is announcing several new updates to the cancer treatment practices listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
  • Recently, the alliance of leading cancer centers published updated versions for several high-incidence cancer types, including breast, colorectal, lung, and pancreatic.
  • Some recent updates to the NCCN Guidelines recommendations include:
    Updates to treatment of HR-positive, early-stage breast cancer, including a new page outlining the general principles for adjuvant endocrine therapy.

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Freitag, März 1, 2024
NSCLC, Progression-free survival, PFS, EGFR, Neoplasm, Magnesium, Diarrhea, FDA, Amivantamab, Food, Cancer, Johnson & Johnson, Nausea, Vomiting, Edema, Risk, ICAN, Constipation, Potassium, IRR, Lung cancer, Toxicity, Neutrophil, Prognosis, COVID-19, NCCN, Fatigue, Death, JNJ, NYU Langone Health, ILD, Drug, Patient, Rash, National Comprehensive Cancer Network, Survival, PAPILLON, Mutation, Appetite, Stomatitis, Pharmaceutical industry

RARITAN, N.J., March 1, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.1 This FDA action converts the May 2021 accelerated approval of RYBREVANT® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Key Points: 
  • The approval of RYBREVANT plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion," said Marcia Horn**, Executive Director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network.
  • We've seen first-hand the extended survival that Exon 20 Group patients experienced on RYBREVANT plus chemotherapy in the PAPILLON study, and we're delighted that this historic treatment option, which specifically targets the EGFR exon 20 insertion mutation, has been approved."
  • "RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations.
  • We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio."

Advocating for Equitable Cancer Care: A Call to Establish Comprehensive Survivorship Programming and Enhance Genetic Testing Discussions

Retrieved on: 
Donnerstag, Februar 22, 2024
Bias, Neoplasm, Cancer, Roger Hawkins (drummer), Somatic, HERC, ACS, Health, World Cancer Day, NCCN, Equity, Organization, Patient, Genetic testing, Biology, Community, Health equity, Estate (law), Pharmaceutical industry

PLYMOUTH MEETING, Pa. and WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- Two new measurements have been added to the Health Equity Report Card (HERC)—a tool for improving the quality and equity of cancer care. The new measures were put forth by a multi-disciplinary working group of experts in community oncology and agreed to by the original Elevating Cancer Equity working group members who drafted the original HERC. This expansion is part of ongoing efforts to address the impact of structural and interpersonal racism as a cause of disparities in cancer outcomes in the United States. The HERC was created by the Elevating Cancer Equity collaboration of the National Comprehensive Cancer Network® (NCCN®), American Cancer Society Cancer Action Network (ACS CAN), and National Minority Quality Forum (NMQF).

Key Points: 
  • The HERC was created by the Elevating Cancer Equity collaboration of the National Comprehensive Cancer Network® (NCCN®), American Cancer Society Cancer Action Network (ACS CAN), and National Minority Quality Forum (NMQF).
  • The two added measurements are:
    Establish comprehensive survivorship programming, including a process for continuity of care when a patient is due for discharge/transfer of care.
  • "These proactive measures are fundamental for promoting equitable healthcare and addressing the disparities that are far too prevalent in cancer care."
  • Visit NCCN.org/policy for more on NCCN's work to improve and facilitate quality, effective, equitable, and accessible cancer care so all patients can live better lives.

China Medical University Hospital (CMUH) in Taiwan Upgrades Smart Healthcare with Gen AI

Retrieved on: 
Samstag, Februar 17, 2024
Cloud, Google Cloud, Workload, Digital health, Hospital, Cancer, Roger Hawkins (drummer), Protein folding, TPU, DHI, Research, Multimedia, HIMSS, Physician, Drug development, Health education, Artificial intelligence in healthcare, Artificial Intelligence Center, Safety, Judgement, NCCN, Patient, Tensor Processing Unit, Data analysis, National Comprehensive Cancer Network, Q&A, Superintendent, Corrado, Tensor, Medical device

TAICHUNG, Feb. 17, 2024 /PRNewswire/ -- China Medical University Hospital (CMUH) in Taiwan announced its collaboration with Google Cloud in mid-December 2023. Using Google Cloud's generative AI technology, including MedLM, which is a large language model built on Med-PaLM 2, CMUH has developed a comprehensive "AI-assisted Physician" system which aims to assist healthcare professionals in disease diagnosis, treatment planning, patient education, and medical research, etc. 

Key Points: 
  • Establishing a comprehensive "AI-assisted Physician" using generative AI from Google Cloud, including MedLM
    TAICHUNG, Feb. 17, 2024 /PRNewswire/ -- China Medical University Hospital (CMUH) in Taiwan announced its collaboration with Google Cloud in mid-December 2023.
  • Through its collaboration with Google Cloud, CMUH is dedicated to driving AI innovation in smart healthcare to shape the future of healthcare in Taiwan.
  • MedLM will help facilitate CMUH in the timely access of accurate medical information to establish the best Healthcare AI models for the Chinese-speaking market in Asia.
  • In this remarkable era of gen AI, we are excited to collaborate with medical industry leaders that drive innovation through AI like CMUH, and partner with them to build the future of healthcare in Taiwan."

Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA

Retrieved on: 
Mittwoch, Februar 14, 2024
CHB, BCR-ABL, FDA, Food, Hepatitis, Safety, Bone marrow, NCCN, Patient, Notifiable disease, National Comprehensive Cancer Network, Mutation, CML, TKI, Cancer, Pharmaceutical industry

Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.

Key Points: 
  • Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.
  • The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma.
  • *Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA  

Retrieved on: 
Dienstag, Februar 13, 2024
Cancer, Neoplasm, Progression-free survival, Caregiver, IPN, EVP, ASCO, Diarrhea, FDA, ADR, Food, Abdominal pain, Pancreatic Cancer Action Network, Hope, Nausea, MBA, Fluorouracil, Vomiting, Dicarboxylic acid, Constipation, Safety, Oxaliplatin, NCCN, Fatigue, PDAC, JD, Patient, Pancreas, Clinical trial, Disease, Phase, UCLA, Pancreatic cancer, Development, Appetite, Category, Pharmaceutical industry

PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).

Key Points: 
  • PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).
  • This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.
  • “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen," said Christelle Huguet, EVP and Head of Research and Development, Ipsen.
  • In the clinical trial, diarrhea was managed following institutional guidelines and appropriate antidiarrheal medications.9
    *NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

McKesson’s Practice Insights Designated as a 2024 Qualified Clinical Data Registry by Centers for Medicare & Medicaid Services

Retrieved on: 
Donnerstag, Februar 8, 2024
Software, Biotechnology, Pharmaceutical, Oncology, Health, Data Management, Technology, Health Insurance, NCCN, Mutation testing, Targeted therapy, National Comprehensive Cancer Network, EHR, Partnership, MIPS, GCSF, Cancer, CMS, Medicare, Innovation, Physician, Distress, McKesson Corporation, Patient, MVP, The Network, Lung cancer, Network

For the eighth consecutive year, McKesson has received approval from the Centers for Medicare & Medicaid Services (CMS) to participate in the Merit-based Incentive Payment System (MIPS) as a Qualified Clinical Data Registry (QCDR).

Key Points: 
  • For the eighth consecutive year, McKesson has received approval from the Centers for Medicare & Medicaid Services (CMS) to participate in the Merit-based Incentive Payment System (MIPS) as a Qualified Clinical Data Registry (QCDR).
  • The designation enables healthcare practices and providers utilizing iKnowMed℠ electronic health record (EHR) to efficiently submit data directly to CMS without engaging a separate registry vendor, streamlining data submission and minimizing administrative burden.
  • As a CMS-approved QCDR, Practice Insights ℠, a performance analytics tool powered by Ontada ®, can collect and report clinical data on behalf of clinicians for standard MIPS measures.
  • It also continues to provide meaningful insights to improve care while simultaneously easing the burden of participating in CMS regulatory programs.

New Resource for Selecting Best Treatment Path for Young Children with Cancerous Tumors Published by NCCN

Retrieved on: 
Mittwoch, Februar 7, 2024
Concurrent estate, Toxicity, Survival, Hospital, Young adult, Child, Immunotherapy, Clinical trial, Children's Hospital of Philadelphia, Patient, NCCN, Brain, Chair, Diagnosis, Conference, Adolescence, Disease, Radiation, Cancer, Pediatrics

PLYMOUTH MEETING, Pa., Feb. 7, 2024 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®)—an alliance of leading cancer centers—today published its first ever set of treatment recommendations pertaining to neuroblastoma. Neuroblastoma is a type of solid tumor cancer that typically occurs in early childhood, with the majority diagnosed before age five.1 Neuroblastoma is the most common type of solid tumor (outside of brain tumors) in children, with more than 700 cases diagnosed in the United States every year.2 Research innovations have led to survival rates that are better than 90% for patients with low- and intermediate-risk neuroblastoma and around 50% for those with high-risk disease.3 Improving outcomes for patients with high-risk neuroblastoma and reducing long-term treatment effects for all patients remain areas of active research.

Key Points: 
  • There are now 87 different NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), covering nearly every type of cancer, plus screening, prevention, and supportive care.
  • The NCCN Guidelines have a long history of providing treatment guidance that correlates with improved outcomes across numerous cancer types.
  • The NCCN Guidelines are intended as a resource for care providers and coverage determinations throughout the U.S. and around the world.
  • There are separate NCCN Guidelines for Survivorship that include additional information on mitigating the long-term impact of treatment.