As a data scientist and software engineer, Razik Yousfi builds artificial intelligence models in health care. He started doing this 15 years ago, long before advanced chatbots catapulted AI into the layman’s consciousness.
The FDA Oncologic Drugs Advisory Committee earlier this week was asked to review two of the slowest-moving confirmatory trials.
FDA approved Keytruda (pembrolizumab) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
FDA approved Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA approved Truqap (capivasertib) with fulvestrant for adult patients with hormone receptor-positive, human epidermal growth factor receptor-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
FDA has granted approval for the HistoSonics’ Edison histotripsy device to treat liver tumors.
FDA approved Fruzaqla (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
FDA revised the existing indication of Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
FDA approved Keytruda (pembrolizumab) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer.
FDA has approved Loqtorz (toripalimab-tpzi) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma.
