FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.
FDA approved a new indication for Cytalux (pafolacianine) to assist surgeons in identifying lung cancer lesions in adult patients with known or suspected lung cancer.
FDA accepted, for priority review, supplemental Biologics License Applications for Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
The Independent Expert Panel for Tobacco submitted its recommendations to Commissioner Robert Califf at FDA. The Operational Evaluation of FDA’s Tobacco Program was facilitated by the Reagan-Udall Foundation at the Commissioner’s request.
The European Commission granted marketing authorization for Ebvallo (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
Caris Life Sciences and Xencor, Inc. expanded their collaboration to research, develop, and commercialize novel XmAb bispecific and multi-specific antibodies directed against novel targets, identified and proposed by Caris, for the treatment of patients with cancer.
C2i Genomics extended its collaboration with AstraZeneca to evaluate the potential of whole-genome minimal residual disease testing across solid cancers, with the goal of enhancing oncology treatment, supporting clinical trial recruitment, and monitoring.
Mersana Therapeutics Inc. and a subsidiary of Merck KGaA in Darmstadt, Germany, formed a research collaboration and commercial license agreement to discover novel Immunosynthen antibody-drug conjugates directed against up to two targets.
Gilead Sciences Inc. and Jounce Therapeutics Inc. amended their existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buyout remaining contingent payments potentially due under the license agreement executed in August 2020.
FDA approved updated labeling for Xeloda (capecitabine) tablets under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
