FDA Approves Piflufolastat F 18 PSMA PET Imaging Agent for Prostate Cancer
May 27th 2021The FDA has approved piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.
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 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.