This post was originally published on this site Bayer and Orion have successfully submitted an application to the European Medicines Agency seeking the approval of darolutamide for men with non-metastatic castration-resistant prostate cancer (nmCRPC). The application follows promising results from the ARAMIS Phase 3 trial (NCT02200614), where a combination of darolutamide and androgen deprivation therapy (ADT) delayed cancer spread by 22 months, compared to…
This post was originally published on this site Women with advanced ovarian cancer who underwent a complete resection of their tumor and have normal lymph nodes do not have better survival outcomes if the lymph nodes surrounding the tumor are removed, and instead, have a higher incidence of complications after surgery, a randomized trial shows. The study,…
This post was originally published on this site Janssen has is seeking approval from the U.S. Food and Drug Administration (FDA) for Darzalex (daratumumab) — in combination with standard Revlimid (lenalidomide) and dexamethasone — as a treatment for newly diagnosed multiple myeloma patients ineligible for a stem cell transplant. Janssen’s supplemental Biologics License Application (sBLA) is based on data from the…
This post was originally published on this site The European Commission has approved a combination of Keytruda (pembrolizumab) plus standard chemotherapy for the initial treatment of metastatic squamous non-small cell lung cancer (NSCLC), Merck (known as MSD outside the U.S. and Canada) announced. The approval — which makes the combination available in all 28 member…
This post was originally published on this site The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Lynparza (olaparib) tablets for the treatment of advanced breast cancer patients whose tumor is HER2-negative and positive for BRCA mutations. The recommendation is for patients already…
This post was originally published on this site Patients with cutaneous T-cell lymphoma (CTCL) who for some reason discontinue their systemic treatments require more monthly emergency room visits, hospital admissions, and longer inpatient stays than those who continue on treatment, a study by the pharmaceutical company Mallinckrodt found. Researchers estimate that, each month, those who…
This post was originally published on this site The first patient has been dosed in Alligator Bioscience’s Phase 1 clinical trial testing the investigational immunotherapy ATOR-1015 as a new treatment for advanced solid tumors, the company announced. The open-label trial (NCT03782467) will assess the safety, tolerability, and early efficacy of ATOR-1015 in approximately 53 adults who failed…
This post was originally published on this site I shivered in the parking lot at my kid’s school with four other moms. Originally, I planned to peel out of there before anyone could see me, but Leeanne caught my eye and then I saw Shannon, and before I knew it, I was parking the car…
This post was originally published on this site Stereotactic body radiotherapy (SBRT), which delivers higher doses of radiation over a significantly shorter period of time, can be safely given to men with low- or intermediate-risk prostate cancer with similar long-term efficacy as conventional radiation therapy, a study shows. The approach, which reduces the duration of treatment…
This post was originally published on this site Adding Celsion‘s GEN-1 to standard chemotherapy — given prior to surgery — stops disease progression in patients with newly diagnosed advanced ovarian cancer and helps remove the tumor successfully during surgery, without causing significant side effects, a Phase 1b trial shows. The trial’s data were presented at the…
