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.

LONDON – New data from a randomized community study involving more than half a million people has shown that of 92,116 who had symptomatic COVID-19, 38% were still reporting symptoms 12 weeks later.

Immvira Group Co. presented positive phase I data for MVR-T3011 as an intratumoral administration at the 2021 American Society of Clinical Oncology meeting, drawing attention to oncolytic viruses developed by Chinese scientists.

Oncohost Ltd. has opened eight U.K. trial sites in the study assessing the ability of its artificial intelligence (AI)-driven proteomics profiling technology to single out which cancer patients will respond to treatment with immune checkpoint inhibitors. The sites will carry out proteomic analyses of blood samples from patients with late-stage melanoma or non-small-cell lung cancer (NSCLC), to predict their likely response to immunotherapy.

Gene therapy specialist Uniqure N.V. said Tuesday that, with confidence inspired by new 52-week data on its investigational hemophilia B therapy, etranacogene dezaparvovec, it plans to submit a BLA for the program with partner CSL Behring LLC in first quarter of 2022. Uniqure meanwhile has moved to acquire Corlieve Therapeutics SAS and its lead program to treat temporal lobe epilepsy, the most common form of focal epilepsy. The acquisition, worth up to €250 million (US$297.3 million) for Corlieve, includes €46.3 million cash up front.