GEJ

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
onsdag, maj 29, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Patient, Progression-free survival, Mesothelioma, Renal cell carcinoma, Neck, ESCC, Risk, Colorectal cancer, Recurrence, Lung cancer, BMY, PFS, Netherlands Cancer Institute, Head, Cisplatin, NSCLC, Cancer, EAC, Congress, GEJ, Civil service commission, European Commission, HR, Death, Melanoma, PR, ESMO, Jan-Arie van der Heijden, European, Checkmate, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
  • With this approval, Opdivo in combination with cisplatin and gemcitabine becomes the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union.
  • “With today’s approval by the EC, we’re pleased to be able to offer Opdivo concurrently with chemotherapy to eligible patients with unresectable or metastatic UC,” said Dana Walker, M.D., M.S.C.E., vice president and global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb.
  • “This is a major step forward for this patient population and reinforces our goal of advancing and delivering new options to patients with difficult-to-treat cancers.

Astellas Showcases Scientific Advancements Across its Oncology Portfolio at 2024 ASCO Annual Meeting

Retrieved on: 
måndag, maj 13, 2024
Patient, Ministry, NMPA, MHLW, CHMP, European Medicines Agency, HER2, Ministry of Health, Dicarboxylic acid, Safety, Zolbetuximab, Cisplatin, BCR, Prostate, GEJ, Research, Prostate cancer, EMA, Cancer, ASCO, Leuprorelin, Abstract, Astellas Pharma, Society, Committee, Oxaliplatin, Quality of life, Annual general meeting, Vaccine

TOKYO, May 13, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research from across its innovative portfolio of approved and investigational cancer therapies during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 - June 4. A total of 16 abstracts will be presented, including new data from pivotal trials supporting ongoing regulatory reviews. The volume of data being presented by Astellas reinforces its commitment to changing the course of cancer treatment through targeted therapies for hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

Key Points: 
  • TOKYO, May 13, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research from across its innovative portfolio of approved and investigational cancer therapies during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 - June 4.
  • A total of 16 abstracts will be presented, including new data from pivotal trials supporting ongoing regulatory reviews.
  • The volume of data being presented by Astellas reinforces its commitment to changing the course of cancer treatment through targeted therapies for hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.
  • "The data at ASCO demonstrate the strength and breadth of our growing oncology portfolio and provide new insights into our transformative therapies for patients living with some of the most devastating cancers.

Fate Therapeutics Reports First Quarter 2024 Financial Results and Business Updates

Retrieved on: 
torsdag, maj 9, 2024
FDA, Investment, Risk, Destiny, IND, Autoimmune disease, Enrollment, Death, Hospital, GAAP, NK, GEJ, Multiple myeloma, CRS, HER2, Pharmacokinetics, Graft-versus-host disease, Food, Lupus, Data, ADR, BCL, Histology, Therapy, BCMA, Autoimmunity, Safety, Trastuzumab, Research, TRAC, Incidence, IPSC, Chronic lymphocytic leukemia, Acute leukemia, Investigational New Drug, Cancer, Cell, Cmax, Patient, Gene, Society, B-cell lymphoma, BCM, Cytokine release syndrome, Immune system, SLE, Vaccine

SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today reported business highlights and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • The patient was discharged after a three-day hospital stay without any notable adverse events.
  • The Company will conduct a conference call today, Thursday, May 9, 2024 at 5:00 p.m.
  • ET to review financial and operating results for the quarter and full year ended March 31, 2024.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Mitigating Muscle Loss Becoming More Vital, Global Cancer Cachexia Market Projected to Reach $3.3 Billion in 2024

Retrieved on: 
onsdag, maj 8, 2024
MSD, PFS, FDA, Pfizer, MRNA, News, Atrophy, Weight loss, Doctor of Philosophy, Vaccine, University of Toronto, PFE, Medicinal chemistry, Medicine, Genome, Moderna, Diagnosis, AstraZeneca, Prevalence, GEJ, University, CPS, HER2, Food, OTC, IHC, Cachexia, Pneumococcal conjugate vaccine, Messenger, Quality of life, RSV, Patient, Facial muscles, Professor, Oncology, Trastuzumab, Research, Incidence, Fatigue, EPS, Neoplasm, MUSL, MRK, Tafamidis, Progression-free survival, PALM, PD-L1, COVID-19, Growth, Pharmaceutical industry

Cachexia is a medical condition known as ‘wasting syndrome’ that causes severe weight loss, muscle loss, and loss of body fats.

Key Points: 
  • Cachexia is a medical condition known as ‘wasting syndrome’ that causes severe weight loss, muscle loss, and loss of body fats.
  • The Cancer Cachexia market refers to the segment of the healthcare industry focused on addressing the multifaceted challenges associated with cachexia in cancer patients.
  • A report from Custom Market Insights projects that the global Cancer Cachexia Market is expected to record a CAGR of 5.1% from 2024 to 2033.
  • In 2024, the market size is projected to reach a valuation of USD 3.3 Billion.

Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Retrieved on: 
onsdag, maj 1, 2024
Biotechnology, General Health, Pharmaceutical, Health, MSD, PFS, CPS, FDA, Congress, HER2, Food, Oncology, Merck & Co., Progression-free survival, Pembrolizumab, Survival, Trastuzumab, ESMO, OS, PD-L1, Patient, Neoplasm, ITT, MRK, GEJ, Pharmaceutical industry

Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.

Key Points: 
  • Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
  • In the U.S., KEYTRUDA is also approved for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, based on results from KEYNOTE-859.
  • Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.

Transcenta Announces Collaboration with Agilent to Develop a Claudin18.2 Companion Diagnostic to Support Osemitamab (TST001) Global Phase III Trial

Retrieved on: 
tisdag, april 9, 2024
IHC, Nivolumab, Partnership, CDX, Patient, Research, Medicine, Agilent Technologies, HKEX, Immunohistochemistry, Therapy, Adenocarcinoma, GEJ, Vaccine

Transcenta has developed a mouse anti-CLDN18.2 monoclonal antibody, clone 14G11 which specifically binds to CLDN18.2 but not CLDN18.1.

Key Points: 
  • Transcenta has developed a mouse anti-CLDN18.2 monoclonal antibody, clone 14G11 which specifically binds to CLDN18.2 but not CLDN18.1.
  • Transcenta has been collaborating with Agilent, a world leader in CDx development, to further develop this antibody for use in a companion diagnostic assay.
  • Agilent and Transcenta presented the early results of the Claudin18.2 IHC 14G11 pharmDx assay at AACR Annual Meeting.
  • "We are excited to be working with Transcenta on the development of the Claudin18.2 IHC 14G11 pharmDx companion diagnostic assay," said Dr. Paul Beresford, VP/GM of CDx, Agilent.

Zai Lab Announces Full-Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
tisdag, februari 27, 2024
Oncology, Mental Health, Health, Infectious Diseases, Neurology, Pharmaceutical, Biotechnology, NSCLC, TED, Blood pressure, Cervical cancer, Psoriasis, Cetuximab, Infection, New Drug Application, SCLC, MAA, National Medical Products Administration, PMA, CIDP, NTRK, FDA, Nivolumab, Food, GEJ, Shanda, Schizophrenia, PDUFA, CRC, Bristol Myers Squibb, BMS, ADP, Safety, Mirati, TPS, Disease, HKT, Patient, Clinical trial, METIS, Fusion, Pancreatic cancer, NDA, NMPA, Pharmaceutical industry

The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.

Key Points: 
  • The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.
  • Zai Lab has joined the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or GEJ cancer in Greater China.
  • Zai Lab to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024.
  • Zai Lab to complete patient enrollment in the China bridging study in schizophrenia in the fourth quarter of 2024.

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
söndag, mars 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

Retrieved on: 
fredag, februari 23, 2024
IIT, ESMO, ASCO, FDA, GEJ, Acceptability, ODD, Stomach, GC, Society, GI, Bone marrow, Patient, Clinical trial, CDE, Oncology, IND, Chinese, Epithelial cell adhesion molecule, Pharmaceutical industry

SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

Key Points: 
  • EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low.
  • IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ".
  • She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China.
  • Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells.

First Refractory Gastric Cancer Patient Dosed in Phase 2 Trial with Novel Combination of MiNK’s Allogeneic INKT Cell Therapy and Agenus’ Botensilimab and Balstilimab

Retrieved on: 
onsdag, februari 14, 2024
Gastrointestinal cancer, Cancer, GEJ, Mink, Stomach, GI, Therapy, Paclitaxel, Patient, Disease, Tissue, Pharmaceutical industry

The trial builds upon findings from MiNK’s recently published clinical trial ( Carneiro et al .

Key Points: 
  • The trial builds upon findings from MiNK’s recently published clinical trial ( Carneiro et al .
  • 2024 Oncogene) demonstrating that agenT-797 appears to overcome resistance to immune checkpoint inhibitors, with durable disease stabilization and a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer.
  • "AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors.
  • This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers.