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.
FDA Approves Frontline Pembrolizumab for HER2+ Gastric, GEJ Cancer
May 5th 2021The FDA granted an accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Adjuvant Nivolumab Granted Priority Review for Muscle-Invasive Urothelial Carcinoma
May 2nd 2021The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab for use as an adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma.
Smartphone Mobile Apps Could Help Patients Monitor and Adhere to Oral Chemotherapy
April 23rd 2021The use of a smartphone mobile app showed that patients with cancer had higher adherence to oral chemotherapy regimens, especially when it came to safely monitoring chemotherapy toxicity and symptoms in real time.
FDA Approves Dostarlimab for dMMR Advanced Endometrial Cancer
April 22nd 2021The FDA approved dostarlimab (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that progressed on or after platinum-containing chemotherapy and whose cancer is DNA mismatch repair deficient (dMMR), as determined by an FDA-approved test.
FDA Approves Sacituzumab Govitecan for Previously Treated Metastatic Urothelial Cancer
April 13th 2021The FDA granted an accelerated approval to sacituzumab govitecan (Trodelvy) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously had a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
FDA Authorizes Marketing for AI Colon Cancer Detection Device
April 12th 2021The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.
Comprehensive Assessment Is Key for Geriatric Patients
April 8th 2021The information provided by the assessment is essential as it contributes to shared decision making. The goal of shared decision-making is for patients and clinicians to partner together and make informed choices based on the patient’s needs, values and preferences.