A combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) worked better than standard Sutent (sunitinib) in improving survival outcomes among adults with untreated advanced renal cell carcinoma (RCC) — the most common type of kidney cancer in adults — according to top-line data from a Phase 3 clinical trial. A different Lenvima combination, with Novartis’ Afinitor (everolimus),…
The U.S. Food and Drug Administration (FDA) has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) as a positron emission tomography or PET imaging agent for men with prostate cancer. The molecule is the first approved PET imaging agent that detects prostate cancer lesions by targeting the prostate-specific membrane antigen (PSMA) — a protein produced at…
The U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on a Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma. In September, the FDA placed a hold on the MELANI-01 trial (NCT04142619) based on safety concerns, after a patient who received…
For the first time, researchers safely and effectively treated cells and mice with ovarian cancer using the CRISPR-Cas9 gene-editing tool plus a newly developed lipid nanoparticle (LNP) delivery system, which targeted and destroyed the cancer cells by genetic manipulation. This new therapeutic strategy has the potential to treat not only other types of cancer, but…
Anixa Biosciences and the Cleveland Clinic have filed an investigational new drug application for a breast cancer vaccine with the U.S. Food and Drug Administration. The vaccine technology was developed by researchers at the Cleveland Clinic. Funding from the U.S. Department of Defense is expected to enable completion of two Phase 1 clinical trials, according…
Women who use assisted reproductive technology to help them conceive a child appear not to be at an increased risk of developing ovarian cancer, a nationwide study conducted in the Netherlands has found. The study, “Long-Term Risk of Ovarian Cancer and Borderline Tumors After Assisted Reproductive Technology,” was published in the Journal of the National…
The U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx to be used as a companion diagnostic test to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are likely to benefit from treatment with Lynparza (olaparib). Developed by Foundation Medicine, the test is a blood-based biopsy assessment approved by the FDA to…
The European Commission has approved Opdivo (nivolumab) as a second-line treatment for adults with advanced inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), who previously were treated with fluoropyrimidine and platinum chemotherapy agents. This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency. With…
The U.S. Food and Drug Administration (FDA) has designated 4D Path’s software a breakthrough device as a possible way to achieve a faster and more accurate breast cancer diagnosis based on tissue taken in a breast biopsy or resection. Named 4D Q-plasia OncoReader Breast, the software is intended to aid doctors in evaluating biopsies and resections (tumors that are surgically…
Xgeva (denosumab) has been approved by the China National Medical Products Administration (NMPA) to prevent bone problems — such as fractures, spinal cord compressions, and the need for radiation or surgery — in people with multiple myeloma and in those with bone metastases from solid tumors. Xgeva was previously approved in China to treat adults, and adolescents…
