West African genetic ancestry was associated with increased prostate cancer among men living in disadvantaged neighborhoods but not among men living in more affluent neighborhoods, according to a new study led by NIH researchers. The findings suggest that neighborhood environment may play a role in determining how genetic ancestry influences prostate cancer risk.
The Wistar Institute’s president and CEO, Dario C. Altieri, and his team have demonstrated the role of Parkin—a protein implicated in Parkinson’s disease—in the body’s innate immune response to cancer. Parkin is not expressed in several cancers. Altieri and his team engineered cancer cells to re-express Parkin and found that Parkin contributes to the production of interferons, which activate and attract T cells to fight the tumor. The lab’s findings were published in The Journal of Clinical Investigation.
FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.
FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
FDA approved Kisqali (ribociclib) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage 2 and 3 early breast cancer at high risk of recurrence.
FDA granted Fast Track designation to ICT01 in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia patients 75 years or older, or who have comorbidities that preclude use of standard intensive induction chemotherapy.
FDA issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials in support of applications for drugs intended to treat cancer.
FDA issued a final guidance, “Conducting Clinical Trials with Decentralized Elements,” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
FDA has issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.
Japan’s Ministry of Health, Labour, and Welfare has accepted for review a new drug application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone or pomalidomide plus dexamethasone as a treatment for relapsed or refractory multiple myeloma.