chemotherapy News
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Symberix Co-Founder Gives Keynote Address at AACR Conference
Symberix co-founder Matthew Redinbo gave the keynote address at the AACR Microbiome, Viruses, and Cancer conference on Friday, February 21, 2020. The special conference covers the contribution of bacterial, viral, and fungal pathogens to the development of cancers, as well as the impact of the microbiome on cancer therapy. Dr. Redinbo’s keynote, titled “Molecular control of the gut ...
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New NCCN Breast Cancer Guidelines Recognise Oncotype DX Breast Recurrence Score as the “Preferred” and Only Multigene Test to Predict Chemotherapy Benefit in Node-positive Early-stage Breast Cancer
Exact Sciences today announced that its Oncotype DX Breast Recurrence Score test has been recognised as the only test that can be used for prediction of chemotherapy benefit in early-stage breast cancer patients with 1-3 positive axillary lymph nodes, including micro metastases, by the National Comprehensive Cancer Network (NCCN)ii in its updated guidelines for breast cancer. iii The Oncotype DX ...
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Lupin and Axantia Enter into a License, Supply and Technology Sharing Agreement for Pegfilgrastim in the Middle East and North Africa
Global pharma major, Lupin Limited (Lupin) announced today that they have entered into a License, Supply and Technology Sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the region operating through its pharmaceutical subsidiaries; Pharma International Company and Med City Pharmaceutical Industries. Under the terms of Agreement, Axantia will register, ...
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Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult Patients with Locally Advanced or Metastatic Urothelial Cancer
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that the European label for KEYTRUDA, Merck’s anti-PD-1 therapy, be updated to include data from KEYNOTE-361, a Phase 3, open-label trial that evaluated KEYTRUDA ...
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New TAILORx Data, Published in JAMA Oncology, Add to Strong Evidence Base Reinforcing Unique Ability of Oncotype DX Breast Recurrence Score Test to Guide Chemotherapy Treatment
Clinical Outcomes in Patients with High Recurrence Score Results Presented in Oral Session at ESMO 2019 Congress With Fourth Peer-Reviewed Publication, TAILORx Continues to Elevate Oncotype DX Test to a New Global Standard Genomic Health on Monday announced results from a new analysis of the Trial Assigning IndividuaLised Options for Treatment (Rx), or TAILORx, which reinforce the unique ...
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FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)
Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castrationresistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. ...
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RxPONDER Study Results Demonstrate that the Oncotype DX Test Can Now Spare Chemotherapy Use in the Majority of Women with Node-positive Early-stage Breast Cancer
First results from the independent SWOG Cancer Research Network-led Phase III study to be presented at the 2020 San Antonio Breast Cancer Symposium RxPONDER results from over 5,000 women likely to transform the treatment of node-positive breast cancer, as the TAILORx study did in node-negative disease Exact Sciences Corp. (NASDAQ: EXAS) today announced that data from the Rx for Positive ...
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Novartis PluvictoTM approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer
Basel, March 23, 2022 — Novartis announced today that the US Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castrationresistant prostate cancer (PSMA-positive ...
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Merck and Pfizer Provide Update on Phase III JAVELIN Gastric 100 Trial
Merck and Pfizer Inc. (NYSE: PFE) today announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer versus continuation of chemotherapy or best supportive care. While the study ...
By Siemens AG
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New Oncotype DX Real-World Evidence Shows for the First Time the Practice-Changing Impact of TAILORx Results
Data obtained in real-life setting from more than 800 patients with node-negative or nodepositive early-stage breast cancer highlight the test’s impact on clinical practice with chemotherapy-sparing effect Publication of landmark TAILORx study results led to greater reduction in chemotherapy recommendations Exact Sciences Corp. today announced results from a prospective clinical ...
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Publication in The New England Journal of Medicine Confirms that Tens of Thousands of Women with Node-positive, Early-stage Breast Cancer Can Avoid Chemotherapy with the Oncotype DX Test
RxPONDER, an independent study led by SWOG Cancer Research Network, demonstrates that guiding treatment with Oncotype DX test can spare chemotherapy use in majority of postmenopausal women Results have already led to updated NCCN Guidelines® for breast cancer New RxPONDER results to be featured in oral presentation at 2021 San Antonio Breast Cancer Symposium (SABCS) Exact Sciences ...
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New Analysis Reinforces Cost-Effectiveness of the Oncotype DX Breast Recurrence Score Test in Node-Positive Early-Stage Breast Cancer
Improved quality of care and significant cost savings using the test to guide adjuvant chemotherapy treatment Analysis based on first results from the independent RxPONDER study which identified the majority of women with one to three positive nodes who receive no benefit from chemotherapy Exact Sciences today announced results from a health economic analysis of the Oncotype DX Breast ...
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Saladax Biomedical Announces Salvatore J. Salamone, Ph.D. Received the Prestigious Dr. C.E. Pippenger Award
Salvatore J. Salamone, Ph.D. received the prestigious Dr. C.E. Pippenger Award at the 2021 International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) annual meeting in Rome, Italy. This award is given to individuals who have made outstanding contributions to the field of Therapeutic Drug Monitoring (TDM). TDM is a field of medical science that seeks to ensure that ...
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xCures partners with RenovoRx to assist patients in accessing RenovoRx’s TIGeR-PaC study
xCures, Inc. is proud to announce their partnership with RenovoRx, a clinical-stage biopharmaceutical company that focuses on fighting cancer through localized treatment of difficult-to-treat tumors, such as pancreatic adenocarcinoma. Through this collaboration, xCures will help eligible pancreatic cancer patients access a Phase III clinical study entitled, Targeted Intra-arterial Gemcitabine vs. ...
By xCures
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New Data and Society Guidelines Support Value of Oncotype DX Breast Recurrence Score Test in Guiding Neoadjuvant Treatment Decisions for Newly Diagnosed Patients
Study results presented at ASCO20 showed that the Recurrence Score results on core biopsies predict the likelihood of response to neoadjuvant chemotherapy Results are particularly relevant in the context of the Covid-19 pandemic which is causing the delay of elective surgeries across health systems worldwide Exact Sciences Corp. today announced results from three studies of the Oncotype DX ...
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New FDA Approval for MSD’s Keytruda
Keytruda or pembrolizumab, MSD’s (Merck in USA/Canada) monotherapy for metastatic small cell lung cancer (SCLC) has been granted accelerated approval by FDA. Keytruda is now indicated for metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This is the latest in the list of approved indications for use in SCLC, which ...
By IMAPAC
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Merck Receives Complete Response Letter From US FDA for Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative ...
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Mesothelioma treatment: a review of the role of the pathologist in mesothelioma
The Department of Pathology at Brigham and Women’s Hospital in Boston, Massachusetts recently published an article on the various roles played by a pathologist throughout the mesothelioma diagnostic and treatment process. The article explores the importance of the pathologist not only in the diagnostic stage, but also in the treatment stage as well. Treatment for malignant mesothelioma is ...
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Sarcoids in horses: Next milestone in cancer therapy
We are glad to announce that scientists from our biotechnology company BlueSky Immunotherapies GmbH (Ltd.) have achieved great success in completely and permanently eliminating equine sarcoids and bovine papillomavirus that causes this aggressive form of skin cancer that horses often suffer from. By using its proprietary delNS technology, BlueSky Immunotherapies has created a viral vector ...
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Ascelia Pharma receives FDA acceptance of IND application for Oncoral clinical trial
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for the upcoming global Phase 2 clinical study in gastric cancer with the daily oral chemotherapy candidate drug Oncoral. “We are very happy that the FDA has accepted our IND application to start our Phase ...
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