Adding Imfinzi (durvalumab) to standard first-line chemotherapy prolongs survival for adults newly diagnosed with inoperable malignant pleural mesothelioma, according to data from a Phase 2 clinical trial. This study is the first to show survival times exceeding 20 months in this patient population. A Phase 3 trial, called DREAM3R (NCT04334759), to confirm the combination’s superiority over…
Category: Cancer
FDA Grants Priority Review to Keytruda for Relapsed or Refractory Classical Hodgkin’s Lymphoma
The U.S. Food and Drug Administration (FDA) has accepted and given priority review to Merck‘s application requesting the approval of Keytruda (pembrolizumab) as a second-line treatment for adults with relapsed or refractory classical Hodgkin’s lymphoma (cHL). The supplemental biologics license application was based on data from the Phase 3 KEYNOTE-204 clinical trial (NCT02684292), in which Keytruda significantly…
Uppsala in Last Preclinical Stage for New CAR T-cell Product for Glioblastoma
Researchers at Uppsala University, in Sweden, in collaboration with the SciLifeLab Drug Discovery and Development Platform, have taken “a large step forward” in developing a potential CAR T-cell therapy for glioblastoma, an aggressive form of brain cancer that is often difficult to treat. Their project is now entering the final preclinical stage of development, according…
First-line Tislelizumab Plus Chemo Under Review in China for Advanced NSCLC
The Chinese Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted for review Beigene’s application seeking approval for tislelizumab, in combination with standard chemotherapy, as a first-line treatment for people with advanced non-squamous non-small cell lung cancer (NSCLC). This is Beigene’s second supplemental new drug application (sNDA) in China for its experimental candidate tislelizumab. The…
EMA Grants Trastuzumab Deruxtecan Accelerated Assessment for Advanced HER2-positive Breast Cancer
The European Medicines Agency (EMA) has validated Daiichi Sanyoko‘s marketing authorization application for trastuzumab deruxtecan (DS-8201) for the treatment of inoperable or metastatic HER2-positive breast cancer, the company announced. The validation means that the application is complete and may now begin the scientific review process by the Committee for Medicinal Products for Human Use. The…
Tecentriq-Chemo Combo Ups Percentage of TNBC Patients With No Cancer at Surgery
When given alongside chemotherapy, Tecentriq (atezolizumab) increases the percentage of people with early triple-negative breast cancer (TNBC) who show no signs of cancer during tumor removal surgery, a Phase 3 trial shows. These results were found regardless of the patient’s PD-L1 status, or the amount of the PD-L1 protein on the individual’s cancer cells. The study,…
Cryotherapy May Ably Treat Intermediate-risk Prostate Cancer
Cryotherapy directed to the cancerous part of the prostate may be an effective and less invasive treatment option for men with intermediate-risk, unilateral prostate cancer, without the common side effects of traditional approaches, a small study suggests. The procedure was well tolerated, and 80% of the men were free of clinically significant disease at six and…
Collaboration Seeks to Reduce Prostate Cancer Disparities in African Americans
The Prostate Cancer Foundation (PCF) and Robert F. Smith, chairman and CEO of Vista Equity Partners are supporting research on a new non-invasive genetic test to determine a man’s risk of developing prostate cancer. Named the Smith Polygenic Risk Test for Prostate Cancer, the tool is part of PCF’s large initiative to reduce prostate cancer…
New Guidelines for Care of Advanced Prostate Cancer Released
The American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) have released new guidelines for the diagnosis and treatment of advanced prostate cancer, the associations announced. These guidelines were developed by a panel of experts that a patient advocate. In addition to their own expertise and experience, panel…
New Risk Calculator May Help Men With High PSA Decide on Having Prostate Biopsy
A new risk calculator may help men with high levels of prostate-specific antigen (PSA) — a marker of prostate cancer — to decide if they should undergo a prostate biopsy to determine if they have cancer. The cancer risk calculator, developed by researchers at Kaiser Permanente Northern California, is specifically designed to calculate the risk…