Panitumumab

EmeritusDX Announces Launch of FDA Approved Therascreen BRAF and KRAS Tests, Expanding Molecular Testing Capabilities

Retrieved on: 
Monday, April 8, 2024
Biopsy, Mutation, Colorectal cancer, Encorafenib, Cetuximab, Patient, Cancer, BRAF, Panitumumab, CRC, FDA, Physician, Health, Pharmaceutical industry

LAKE FOREST, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- EmeritusDX, a leading cancer diagnostics and information company, is excited to announce the launch of the FDA-approved therascreen® BRAF and KRAS tests. These innovative products represent a significant advancement in the company's molecular testing menu and aligns perfectly with its strategy of enhancing patient care.

Key Points: 
  • LAKE FOREST, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- EmeritusDX, a leading cancer diagnostics and information company, is excited to announce the launch of the FDA-approved therascreen® BRAF and KRAS tests.
  • These innovative products represent a significant advancement in the company's molecular testing menu and aligns perfectly with its strategy of enhancing patient care.
  • "The introduction of the therascreen® BRAF and KRAS portfolio is a testament to this commitment.
  • According to EmeritusDX's Chief Scientist, Dr. Vincent Funari, "The therascreen® BRAF and KRAS tests are a game-changer in personalized medicine for CRC patients.

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Tuesday, February 27, 2024
Research, New Drug Application, Vomiting, Common, Rash, Multiple myeloma, Patient, Orange Book, Investigational New Drug, Neoplasm, Nausea, Panitumumab, BCMA, Therapy, European Medicines Agency, Food and Drug Administration, Plantar fibromatosis, MAPK, NDA, EGFR, Diarrhea, Patent, B-cell maturation antigen, IND, MEK, NRAS, Security, EMA, Aes, MAA, FDA, Research and development, Food, TEA, RAF, Medicare, NCCN, Administration, Cancer, Pharmaceutical industry

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

Powered by Its Industry-Leading Comprehensive Multi-Modal Database, Caris Life Sciences to Showcase Research at ASCO Gastrointestinal Cancers Symposium 2024

Retrieved on: 
Wednesday, January 17, 2024
Panitumumab, MSI, NGS, Patient, EGFR, Research, Cancer, MD, CTX, ASCO, Diagnosis, Cetuximab, CCA, AI, Society, NCI, Prognosis, TMB, FGFR2, Immunotherapy, FACP, Mutation, MBA, APC, Biomarker, CRC, POA, Abstract, GI, Medicine, Prevalence

IRVING, Texas, Jan. 17, 2024 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, announced today that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present 11 studies across six solid tumor types at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco. The findings demonstrate the power of Caris' comprehensive multi-modal database to enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment.  

Key Points: 
  • "We are proud to again present a wide array of precision oncology research at this year's ASCO GI.
  • Strikingly, patients with early-onset CCA experience better outcomes from immunotherapy even though immune-oncology-relevant markers like MSI and TMB favors average-onset CCA.
  • Two posters use EGFRi-treated CRC samples from the Caris multi-modal database to explore two promising possibilities: APC mutation status and CTX sensitivity score (CTX-S).
  • The POA includes 90 cancer centers, academic institutions, research consortia and healthcare systems, including 42 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research.

SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Regeneron Pharmaceuticals, Initiate, Conference, AACR, Orange Book, MAPK, Amgen, IND, B-cell maturation antigen, FDA, EMA, BeiGene, EGFR, MAA, Pain, Multiple myeloma, NDA, BCMA, Therapy, Cancer, Investigational New Drug, Event, First grade, Standard of care, TEAD, Neoplasm, Plantar fibromatosis, European Medicines Agency, RAF, European Hematology Association, CD3, MEK, Webcast, NRAS, RAS, Patient, Panitumumab, Pharmaceutical industry

Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

Key Points: 
  • Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.
  • These presentations demonstrated rapid, sustained and consistent improvements in pain and functional status in patients receiving OGSIVEO using multiple assessment tools.
  • Initiate Phase 1 trial of SW-682, SpringWorks’ TEAD inhibitor, in Hippo mutant solid tumors in the first half of 2024.
  • A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

Treadwell Announces Strategic Pipeline Prioritization and Leadership Transitions

Retrieved on: 
Wednesday, December 6, 2023
Workforce, Gene editing, TTK, Amgen, Breast cancer, Royal college, TCR, FDA, Acquisition, Cell, Research, Internal medicine, Drug, Physician, SAN, Panitumumab, Therapy, Oncology, Cancer, University, HPK1, Queen's University, Roivant Sciences, Patient, Surgeon, AML, PLK4, Pharmaceutical industry

TORONTO and SAN FRANCISCO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Treadwell Therapeutics, a clinical-stage biotechnology company developing novel first-in-class medicines for unmet needs in cancer, today announced that it is realigning its pipeline, workforce and management structure to support its highest value program and extend its cash runway to prioritize the execution of key near term value drivers and clinical milestones.

Key Points: 
  • Dr. Sidhu brings to Treadwell an extensive track record of success over the last nearly 20 years in hematologic and solid tumor oncology research and development.
  • “Roger brings a unique and broad set of skills and strategic thinking to Treadwell over a long and successful career.
  • We are confident that under his leadership, Treadwell will aggressively advance into an exciting new chapter in our mission to address unmet needs in difficult to treat cancers with first-in-class medicines,” said Shane Burgess, Executive Chair of Treadwell Therapeutics.
  • We would like to extend our deep gratitude to the Treadwell team, investigators and patients involved in our clinical programs.

SpringWorks Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, November 2, 2023
Bispecific monoclonal antibody, Cycle, Patient, NRAS, FDA, Molecular Cancer Research, Research, Research and development, New Drug Application, IND, American Association for Cancer Research, CD3, PDUFA, Multiple myeloma, Amgen, TEAD, Biotechnology, Regeneron Pharmaceuticals, MAPK, Prescription Drug User Fee Act, Plantar fibromatosis, G&A, European Medicines Agency, Panitumumab, R, RAF, Solar cycle 10, MEK, Growth, Common, Annual general meeting, EMA, Solar cycle 2, NDA, Cancer, Therapy, Solar cycle 24, BCMA, Administration, BeiGene, EGFR, Pharmaceutical industry, Medical imaging

STAMFORD, Conn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2023 and provided an update on recent business highlights.

Key Points: 
  • – PDUFA target action date for nirogacestat NDA in adults with desmoid tumors remains set for November 27, 2023 –
    STAMFORD, Conn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2023 and provided an update on recent business highlights.
  • SpringWorks expects to file a Marketing Authorisation Application for nirogacestat with the European Medicines Agency (EMA) in the first half of 2024.
  • SpringWorks plans to file an IND for SW-682, the Company's TEAD inhibitor development candidate, in the fourth quarter of 2023.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $79.4 million, or $1.27 per share, for the third quarter of 2023.

AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS VECTIBIX® (PANITUMUMAB) DATA IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER

Retrieved on: 
Sunday, October 22, 2023
Patient, Research, ESMO, Progression-free survival, Trae tha Truth, Trifluridine, DCR, Magnesium, Diarrhea, Congress, PFS, European Society for Medical Oncology, KRAS, Rash, Amgen, Research and development, Liver disease, The New England Journal of Medicine, Oncology, AMGN, ORR, Istituto nazionale per l'assicurazione contro gli infortuni sul lavoro, The Codebreakers, Pharmaceutical industry, Medical imaging, Panitumumab

THOUSAND OAKS, Calif., Oct. 22, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced data from the global Phase 3 CodeBreaK 300 trial evaluating two doses of LUMAKRAS® (sotorasib) (960 mg or 240 mg) in combination with Vectibix® (panitumumab). Both doses demonstrated a statistically significant superiority in progression-free survival (PFS) over the investigator's choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The results are being presented today at the Presidential Symposium 2 session as a late-breaking oral presentation (LBA10) during the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain, with simultaneous publication in the New England Journal of Medicine.

Key Points: 
  • Both doses demonstrated a statistically significant superiority in progression-free survival (PFS) over the investigator's choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC).
  • Among secondary endpoints, higher objective response rate (ORR) and disease control rate (DCR) were observed in patients treated with LUMAKRAS plus Vectibix at both doses versus investigator's choice of care.
  • Patients at both dose regimens of LUMAKRAS plus Vectibix experienced a longer duration of treatment than those treated with investigator's choice therapy.
  • Based on the CodeBreaK 300 primary analysis results, Amgen is planning to submit these data to regulatory authorities.

AMGEN TO PRESENT NEW RESEARCH FROM ONCOLOGY PORTFOLIO AND PIPELINE AT ESMO 2023

Retrieved on: 
Monday, October 16, 2023
Keypad, Abstract, Breast cancer, FOLFIRI, Oncology, ESMO, SD, Carcinoma, Colorectal cancer, European Society for Medical Oncology, AMGN, Cancer, KRAS, Myalgia, Cytokine release syndrome, RAS, Hitachi HD44780 LCD controller, MA, Prostate cancer, PR, Love at First Bite, NSCLC, PAN, SCLC, Fever, CRC, Denosumab, Fatigue, CRS, Renal cell carcinoma, ESME, Heath Robinson (codebreaking machine), Congress, Biomarker, AMG, Research and development, Panitumumab, Pembrolizumab, AM, Metastasis, STEAP1, Prostate, Pharmaceutical industry, Medical imaging, Book, Entertainment, Communications satellite, Research, Amgen, Patient

THOUSAND OAKS, Calif., Oct. 16, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across its broad oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20-24 in Madrid. Results from Amgen-sponsored and collaborative studies, including two late-breaking oral presentations, will feature data in a range of tough-to-treat cancers.

Key Points: 
  • Results from Amgen-sponsored and collaborative studies, including two late-breaking oral presentations, will feature data in a range of tough-to-treat cancers.
  • "Our data at ESMO demonstrate the rapid progress we are making in advancing a portfolio with first-in-class therapies, including metastatic KRAS G12C mutated colorectal cancer and small cell lung cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "These findings illustrate how we are attacking cancer from many different angles to deliver new approaches poised to alter the natural history of disease across many cancers."
  • Amgen will present data from two late-breaking abstracts at ESMO:
    Results from CodeBreaK 300 (Abstract #LBA10), a global, registration-enabling Phase 3 trial evaluating LUMAKRAS (sotorasib) combined with Vectibix (panitumumab) in chemorefractory KRAS G12C-mutated metastatic CRC.

EntroGen Receives FDA Approval for CRCdx® RAS Mutation Detection Kit as Companion Diagnostic for Vectibix®

Retrieved on: 
Wednesday, October 4, 2023
NRAS, KRAS, Colorectal cancer, FDA, PMA, Patient, Laboratory, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Panitumumab, Medicine, Pharmaceutical industry

LOS ANGELES, Oct. 3, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted approval for EntroGen's CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted therapy used in the treatment of colorectal cancer.

Key Points: 
  • LOS ANGELES, Oct. 3, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted approval for EntroGen's CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted therapy used in the treatment of colorectal cancer.
  • This landmark premarket approval (PMA) marks a significant advancement in precision medicine for colorectal cancer patients in that CRCdx® is the first approved real-time PCR-based test in the U.S. that fully meets the biomarker identification requirement for Vectibix®.
  • The CRCdx® RAS Mutation Detection Kit is a cutting-edge molecular diagnostic tool designed to accurately detect KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.
  • "We expect CRCdx® to improve access to RAS testing at small and mid-size laboratories by simplifying the testing procedure while improving the turnaround time and lowering the diagnostic costs," said Matthew Minkovsky, CEO of EntroGen.

AMGEN PRESENTS NEW SCIENTIFIC AND CLINICAL RESEARCH ACROSS ITS DIVERSE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023

Retrieved on: 
Thursday, June 1, 2023
AMGN, KRAS, Amgen, KID, Osteoporosis, Research and development, Plasma, RAS, Patient, Panitumumab, Blinatumomab, Myelodysplastic syndrome, Carcinoma, CT, Bi-specific T-cell engager, Multiple myeloma, Panama, Lenalidomide, Lung cancer, MRD, Heath Robinson (codebreaking machine), Inotuzumab ozogamicin, Docetaxel, Abstract, Metastasis, RCT, Cancer, Carfilzomib, NSCLC, Denosumab, Sarcoma, Colorectal cancer, Biomarker, Busulfan, Neoplasm, Pembrolizumab, CRC, Dexamethasone, SCLC, ASCO, Talimogene laherparepvec, American Society of Clinical Oncology, ASCT, Melanoma, Annual general meeting, CDT, Melphalan, Society, Pharmaceutical industry, Medical imaging, Communications satellite, Flour, Glass wool, Vaccine, Nursing, Book, Takeda, Allotransplantation, Research

THOUSAND OAKS, Calif., June 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its diverse oncology portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago. More than 25 abstracts from Amgen-sponsored and collaborative studies, including three oral presentations and two poster discussions, will feature data in hard-to-treat tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and small cell lung cancer (SCLC).

Key Points: 
  • Additional Analyses from DeLLphi-300 Highlight Safety and Clinical Efficacy of Tarlatamab, an Investigational First-in-Class BiTE® Immunotherapy, in Patients with SCLC With Treated and Stable Brain Metastases
    THOUSAND OAKS, Calif., June 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its diverse oncology portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago.
  • More than 25 abstracts from Amgen-sponsored and collaborative studies, including three oral presentations and two poster discussions, will feature data in hard-to-treat tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and small cell lung cancer (SCLC).
  • "Our presentations at ASCO will illustrate how we're advancing novel approaches to address the toughest thoracic and colorectal cancers with limited treatment options," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "We're focused on expanding the reach and impact of our transformative, first-in-class medicines to help more people living with cancer."