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.
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.
FDA approved Tecentriq (atezolizumab) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma.
FDA has granted an accelerated approval to Krazati (adagrasib), a RAS GTPase family inhibitor, for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
The past six weeks have brought fundamental change in the way oncology drugs are being developed. At this unprecedented moment in oncopolitics, FDA, NCI, academic oncologists, advocates, and the industry are in agreement on how cancer therapies should be developed, tested and approved.
Pragmatica-Lung is shaping up as the clinical trial to watch—not just because of the research question, but because of the way it’s being addressed.
Pragmatica-Lung is the first of what is likely to be a series of simpler trials with relaxed enrollment criteria and streamlined data collection requirements.
The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research.
