To date, there is a lack of consensus in anal cancer screening. DNA methylation markers zing finger protein 582 (ZNF582) and achaete-scute homolog 1 (ASCL1) have been associated with anal intraepithelial neoplasia (AIN3) and anal carcinoma risk in people with HIV infection.
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
Accelerated approval based on a phase II single-arm trial doesn’t appear to be in the cards for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic squamous cell anal cancer (SCAC). Following the lead of FDA reviewers June 24, the agency’s Oncologic Drugs Advisory Committee (ODAC) voted 13-4 to recommend that the agency defer its approval decision until more data are available from POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC.
With the July 25 PDUFA priority review date looming for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic anal cancer, the FDA has one voting question for its Oncologic Drugs Advisory Committee (ODAC): Should it hold off on its approval decision until more data are in from a phase III study?
The question of whether Rubius Therapeutics Inc. would disclose data with its cellular therapy, RTX-240, ahead of the American Association for Cancer Research (AACR) meeting next month was answered in a market-satisfying way as the Cambridge, Mass.-based firm rolled out positive findings from the ongoing phase I/II experiment.