Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
FDA OKs Adjuvant Nivolumab to Treat High-Risk Urothelial Carcinoma
August 20th 2021The Food and Drug Administration approved adjuvant nivolumab to treat urothelial carcinoma in patients who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
Early Study Results Show Novel Combo Therapy May Be Effective in Lung Cancer Subtype
July 14th 2021The preliminary results of an early-phase study of rigosertib combined with nivolumab for the treatment of advanced metastatic KRAS-mutated non-small cell lung cancer are scheduled to be presented at an upcoming medical conference.
FDA Approves Enfortumab Vedotin for Treatment of Locally Advanced or Metastatic Urothelial Cancer
July 9th 2021“For the first time, physicians can treat advanced urothelial cancer following treatment with a platinum-containing therapy and immunotherapy using an FDA-approved therapy that has demonstrated an OS benefit compared with chemotherapy.”
FDA Grants Priority Review to Maribavir for Post-Transplant Recipients With Cytomegalovirus
May 25th 2021The FDA has accepted a new drug application for maribavir for the treatment of post-transplant recipients with cytomegalovirus infection who are refractory and/or resistant to previous anti-CMV treatment.
FDA Grants Sintilimab/Pemetrexed Review for Frontline Nonsquamous NSCLC
May 19th 2021A biologics license application for sintilimab injection plus pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer has been accepted for FDA review.
FDA Approves Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria
May 17th 2021The FDA has approved pegcetacoplan (Empaveli) for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve and those who are switching from the C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris).
AI-Based Focal Therapy System Get a Breakthrough Device Designation for Prostate Cancer Treatment
May 12th 2021The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.