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Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.Relapse is common in multiple myeloma, and when it happens, a drug that worked for a patient before might no longer help. Two cell therapies already approved for this cancer may now be used in earlier lines of treatment, a regulatory decision that brings additional choices for patients who have exhausted standard multiple myeloma treatment options. Multiple myeloma is a blood cancer that develops in the plasma cells in bone marrow. The expanded FDA approvals announced Friday cover Abecma, from Bristol Myers Squibb and 2seventy bio, and Carvykti, from Johnson & Johnson and Legend Biotech. Both products are CAR T-therapies made by engineering a patient’s own immune cells to go after BCMA, a protein ...
- Source: drugdu
- 97
- April 10, 2024
Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors

Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
- Source: drugdu
- 128
- April 10, 2024
Simple PCR Assay Accurately Differentiates Between Small Cell Lung Cancer Subtypes

Small cell lung cancer (SCLC), a rapidly progressing neuroendocrine malignancy, exhibits low survival rates. Despite its molecular and clinical heterogeneity, SCLC is presently treated as a single entity, without the use of predictive biomarkers, which leads to poor patient outcomes. Recent research has proposed dividing SCLC into four subtypes—labeled “A”, “N”, “P”, and “I”—each characterized by distinct molecular signatures and treatment vulnerabilities. Initially, this classification relied on gene expression (RNA-seq) data. Further studies indicated that the same categorization could be recapitulated through the use of a reduced-representation bisulfite sequencing (RRBS) methylation profile. Although this classification system effectively predicts treatment responses, including to immunotherapy, in retrospective analyses, both RNAseq and RRBS techniques are too labor-intensive and slow for quick treatment decisions in an aggressive malignancy. Now, a pilot study published in the journal Cancer Cell has demonstrated the feasibility of a simple PCR assay to accurately differentiate between SCLC SCLC subtypes. ...
- Source: drugdu
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- April 10, 2024
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections

Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West Nile, and Zika viruses are the four most significant arboviruses of concern, all being transmitted by mosquito bites. In 2023 alone, dengue virus accounted for over five million cases and 5,000 deaths worldwide. Traditionally, assessing the risk of arboviruses in blood donors has relied on single-pathogen tests, dual-pathogen tests, or donor history questionnaires, with those having traveled to or lived in areas endemic for arboviruses being temporarily deferred. Now, an in vitro nucleic acid test that can detect all four types of arboviruses can help minimize the risk of blood transfusion-transmitted infections. The new Procleix ArboPlex Assay from Grifols (Barcelona, Spain;) is an automated nucleic acid test (NAT) specifically validated for screening blood donors to detect chikungunya, dengue, West Nile and Zika viruses. The ...
- Source: drugdu
- 93
- April 10, 2024
Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

Shanghai, China & JERSEY CITY, N.J. – April 8, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint ...
- Source: drugdu
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- April 10, 2024
Hengrui Adebelizumab, SHR-A1811 Combination Chemotherapy for HER2 Expressing Adenocarcinoma of Gastric or Gastroesophageal Bundle Phase Ib/II Clinical Trial Approved

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. have received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which authorizes to conduct the Phase Ib/II clinical study of Adebelizumab Injection in combination with SHR-A1811 and chemotherapy for HER2-expressing advanced adenocarcinoma of the stomach or the gastroesophageal junction. In 2020, gastric cancer ranked 5th in global cancer incidence and 4th in mortality. Among them, 43.9% of new cases and 48.6% of deaths will occur in China, with 479,000 new cases and 374,000 deaths, both ranking third in China in terms of cancer incidence and mortality. Human Epidermal Growth Factor Receptor (HER2)-positive gastric cancer is a unique subtype of the disease, which requires different diagnostic and therapeutic strategies from HER2-negative gastric cancer. The global reported HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in ...
- Source: drugdu
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- April 10, 2024
Unitaid funds over £6m to Liverpool researchers to treat major diseases

A research project led by the University of Liverpool has been awarded over £6m by Unitaid, a global health initiative to prevent, diagnose and treat major diseases in low- and middle-income countries (LMICs) and to advance long-acting therapeutics to treat or prevent tuberculosis, malaria and hepatitis C. First launched in 2020, the LONGEVITY project aims to ensure that therapeutics for these conditions are easily accessible in LMICs as part of the University of Liverpool’s Centre of Excellence for Long-acting Therapeutics (CELT). To date, the project has already accomplished preclinical proof of concept for long-acting medications for tuberculosis, an infectious disease caused by a bacterium that affects the lungs, and a therapy for the hepatitis C virus, which can lead to liver infection. Caused by a parasite transmitted through bites of infected mosquitoes, malaria is responsible for an estimated 247 million cases, according to the World Health Organization’s 2022 World Malaria ...
- Source: drugdu
- 140
- April 10, 2024
Alliance Healthcare launches cancer symptom referral scheme in UK pharmacies

Around three million people in the UK were estimated to be living with cancer in 2022 Alliance Healthcare has announced it has opened access to UK pharmacies of its ‘Not Normal for You?’ (NNFY) cancer symptom referral scheme to allow pharmacists to refer patients showing potential cancer symptoms to their GPs. The expansion follows the successful launch of the scheme across Alphega Pharmacy’s network, a brand under Alliance Healthcare comprising a network of independent pharmacies across the world. According to Macmillan Cancer Support, around three million people in the UK were estimated to be living with cancer in 2022. The most common cancers in the UK are breast cancer, which accounts for 15% of all cases, followed by prostate cancer (14%), lung cancer (13%) and bowel cancer (11%). As part of the rollout, Alliance Healthcare will provide pharmacies with marketing materials such as leaflets and referral cards, free of charge, ...
- Source: drugdu
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- April 10, 2024
Regular late-life exercise has a beneficial impact on DNA damage and telomere dysfunction

Regular aerobic exercise later in life prevents genomic instability characterized by DNA damage and telomere dysfunction, according to a study from the Department of Internal Medicine at the University of Utah. Researchers will present their work this week at the American Physiology Summit, the flagship annual meeting of the American Physiological Society (APS), in Long Beach, California. Jisok Lim, PhD, said, “These new findings will greatly impact our understanding of the mechanisms on how aerobic exercise improves vascular health at the level of genomic stability.” Late-life exercise used to be thought of as ineffective. However, existing studies indicate aerobic exercise later in life lowers the risk of cardiovascular disease-related mortality. Yet, the specific factors contributing to this effect have not been completely understood. Researchers examined whether regular exercise with aging may prevent DNA damage and telomere dysfunction. Telomeres are protective caps at the end of chromosomes. In this study, exercise ...
- Source: drugdu
- 85
- April 9, 2024
Heavy alcohol use linked to increased risk of Type 2 diabetes in middle-aged adults

Heavy alcohol use may increase middle-aged adults’ risk of developing Type 2 diabetes, according to research to be presented this week at the American Physiology Summit in Long Beach, California. The Summit is the flagship annual meeting of the American Physiological Society (APS). Heavy alcohol use is defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as five or more drinks per day or 15 or more drinks per week for men and, for women, more than four drinks per day or eight or more drinks per week. Heavy alcohol use can diminish liver and pancreas function. Reduced function of these organs in turn can affect control of glucose (blood sugar) in the body. In regard to heavy drinking, research suggests young adults do not typically experience severe impairment of fasting glucose levels and insulin resistance. However, as the U.S. population ages, the number of people that develop ...
- Source: drugdu
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- April 9, 2024

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