JAMA Oncology

BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, April 23, 2024
Biotechnology, Pharmaceutical, Health, Oncology, PFS, Patient, Paclitaxel, Hospital, Food, European Commission, Neutropenia, JAMA Oncology, Survival, BGNE, Tislelizumab, Docetaxel, ESCC, European, Disease, Journal, Pemetrexed, Leukopenia, Neoplasm, Civil service commission, Carboplatin, ALK, EGFR, NSCLC, European Medicines Agency, Overalls, Lung cancer, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
  • “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

MyProstateScore 2.0 Clinically Validated in New JAMA Oncology Study

Retrieved on: 
Thursday, April 18, 2024
Lynx, Urine, Organization, U-M, University, Cancer, Urology, U24, JAMA, Prostate cancer, Prostate Cancer Foundation, ANN, Risk, JAMA Oncology, American Medical Association, Vanderbilt University, MPS2, American Cancer Society, PSA, Research, Therapy, Patient, NCI, Paper, Validation, Biopsy, EDRN, MBA, Biomarker, Howard Hughes Medical Institute, Data management, Journal, Medical imaging

ANN ARBOR, Mich., April 18, 2024 /PRNewswire/ -- Lynx Dx, a leader in innovative diagnostic solutions, hailed new peer-reviewed research published today in the Journal of the American Medical Association (JAMA) Oncology that validates the efficacy of MyProstateScore 2.0 (MPS2), the company's groundbreaking prostate cancer risk assessment test. The findings signify a major advancement in the ability to make highly accurate, comprehensive and personalized predictions by raising the performance standard for urine biomarker tests intended to detect clinically significant prostate cancer.

Key Points: 
  • Further, more than 75% of men with an elevated PSA will have a biopsy negative for clinically significant cancer.
  • In the clinical validation of MPS2 published in JAMA Oncology, scientists evaluated whether MPS2 could improve prostate cancer screening outcomes relative to existing biomarkers.
  • Key findings from the paper include:
    MPS2 was clinically validated separately in patients presenting for initial biopsy (i.e., biopsy naïve) and those presenting for a repeat biopsy (i.e., prior negative biopsy).
  • Paper cited: "Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer," JAMA Oncology.

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

Retrieved on: 
Monday, April 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Wednesday, March 20, 2024
Research, General Health, Pharmaceutical, Oncology, Public Relations, Investor Relations, Clinical Trials, Science, Biotechnology, Communications, Practice Management, Other Science, Health, Fulvestrant, Carcinoma, Progression-free survival, Patient, JAMA Oncology, Pharming, Biomarker, CDK, Letrozole, IND, Triple-negative breast cancer, Puma Biotechnology, Cancer, Paclitaxel, Breast cancer, Anastrozole, Tamoxifen, FDA, Food, Pharmaceutical industry

This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.

Key Points: 
  • This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.
  • Puma plans to initiate this trial in the second half of 2024.
  • Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial.
  • We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

Retrieved on: 
Wednesday, March 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Brain, NSCLC, New Drug Application, Patient, JAMA Oncology, NDA, Anaplastic lymphoma kinase, Crizotinib, Safety, File, Holding, Food, ALK, PDUFA, Pharmaceutical industry

Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Key Points: 
  • Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
  • The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC.
  • The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
  • In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

SMC Laboratories Reveals Innovative STAM™-HCC/IO+ Mouse for Identifying and Developing Novel Therapeutic Drugs for Liver Cancer, Blazing a Trail in the Immuno-Oncology Field

Retrieved on: 
Tuesday, February 6, 2024
Inflammation, Growth, Liver cancer, Immunity, Immunotherapy, Research, JACC, Therapy, Prevalence, Tan, Metabolic syndrome, PNAS, MOA, JAMA Oncology, Sorafenib, Fibrosis, Bevacizumab, Immunogenic cell death, Laboratory, ICIS, Metabolism, Pembrolizumab, Neoplasm, MASH, Nivolumab, Hepatology, Liver, Cancer

The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.

Key Points: 
  • The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.
  • Furthermore, it can be used for testing molecular target drugs and immune checkpoint inhibitors, and for other therapeutic targets while performing stable drug efficacy evaluations.
  • As the prevalence of liver cancer increases, it is anticipated that SMC Laboratories' STAM™-HCC/IO+ mouse will greatly contribute to the development of therapeutic drugs for liver cancer in the future.
  • Liver cancer is the fourth most common type of cancer in the world (Huang DQ et al, Nature Reviews Gastroenterology & Hepatology, 18, 223-238, 2021).

SMC Laboratories Reveals Innovative STAM™-HCC/IO+ Mouse for Identifying and Developing Novel Therapeutic Drugs for Liver Cancer, Blazing a Trail in the Immuno-Oncology Field

Retrieved on: 
Tuesday, February 6, 2024
Inflammation, Growth, Liver cancer, Immunity, Immunotherapy, Research, JACC, Therapy, Prevalence, Tan, Metabolic syndrome, PNAS, MOA, JAMA Oncology, Sorafenib, Fibrosis, Bevacizumab, Immunogenic cell death, Laboratory, ICIS, Metabolism, Pembrolizumab, Neoplasm, MASH, Nivolumab, Hepatology, Liver, Cancer

The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.

Key Points: 
  • The STAM™-HCC/IO+ mouse is a model that allows stable evaluation of the growth of multiple target lesions originating from the liver over a certain period.
  • Furthermore, it can be used for testing molecular target drugs and immune checkpoint inhibitors, and for other therapeutic targets while performing stable drug efficacy evaluations.
  • As the prevalence of liver cancer increases, it is anticipated that SMC Laboratories' STAM™-HCC/IO+ mouse will greatly contribute to the development of therapeutic drugs for liver cancer in the future.
  • Liver cancer is the fourth most common type of cancer in the world (Huang DQ et al, Nature Reviews Gastroenterology & Hepatology, 18, 223-238, 2021).

Sunstone Therapies Announces Publication of Positive Phase 2 Study Results in Cancer

Retrieved on: 
Monday, December 18, 2023
Psilocybin, Clinical trial, Depression, MADRS, Safety, Patient, JAMA Oncology, DSM-IV codes, Pharmaceutical industry

Thirty participants completed the study, with results indicating that psilocybin-assisted therapy in group cohort administration was safe, feasible, and effective.

Key Points: 
  • Thirty participants completed the study, with results indicating that psilocybin-assisted therapy in group cohort administration was safe, feasible, and effective.
  • These results showed that the group approach is feasible and many patients believed it to be of additional benefit.
  • A second study published in Cancer led by Yvan Beaussant, MD, MSc, of Dana-Farber Cancer Institute, gathered information from patients in the trial using exit interviews.
  • Efficient, scalable delivery while maintaining safety is a key issue for psilocybin-assisted therapy and the results of this study suggest a pathway towards wider and faster adoption in the future.”

Sunstone Therapies Celebrates Three Year Anniversary With More Than 100 Psychedelic-Assisted Therapy Treatments Completed

Retrieved on: 
Thursday, December 14, 2023
Veteran, Spectrum, Journal of Affective Disorders, Journal of Psychopharmacology, MAPS, Research, Psychopharmacology, Ketamine, JAMA Oncology, DSM-IV codes, Education, Palliative care, Cancer, University, Sunstone, Post-traumatic stress disorder, Patient, PAT, Journal, Johns Hopkins, Pharmaceutical industry

Rockville, Maryland, December 14, 2023 – Sunstone Therapies, a leader in the delivery of psychedelic-assisted therapy in the medical setting and the development of clinical trials, announces it has completed more than 100 psychedelic-assisted therapy (PAT) treatments, involving eight different indications, in the three years since the company was founded.

Key Points: 
  • Rockville, Maryland, December 14, 2023 – Sunstone Therapies, a leader in the delivery of psychedelic-assisted therapy in the medical setting and the development of clinical trials, announces it has completed more than 100 psychedelic-assisted therapy (PAT) treatments, involving eight different indications, in the three years since the company was founded.
  • Manish Agrawal MD, CEO and Co-founder of Sunstone Therapies, said: “The development of psychedelic-assisted therapy, and the understanding of the impact it can have, has progressed so much over the last three years.
  • We are using the extensive experience we have gained in delivering these therapies, through sponsored clinical trials and our own investigator-initiated studies, to develop a patient-centric delivery model that can be scaled responsibly in the real world.
  • Delivery of psychedelic therapies is complex, requiring significant capabilities and experience in logistics, infrastructure and training, as well as clinical care.