NEW YORK – Legend Biotech said this week the US Food and Drug Administration granted priority review for the biologics license application, or BLA, submitted by Janssen for their BCMA-directed CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel). Legend Biotech and Janssen entered into an exclusive worldwide license and collaboration agreement to develop and commercialize cilta-cel in 2017. Janssen submitted the BLA for cilta-cel in December, seeking approval for it as a treatment for relapsed or refractory multiple myeloma. The FDA is slated to issue a decision on the application under priority review by Nov. 29. Janssen also submitted a marketing authorization application with the European Medicines Agency in April for cilta-cel for this same indication.
The Center for Genomic Interpretation announced this week that it has launched the ElevateGenetics Brilliant Program, a technical competency assessment to evaluate the accuracy of genetic and genomic lab findings. The program will assess how well DNA sequencing tests can detect and classify important mutations and therapeutic biomarkers, particularly in genetic sequences that are technically challenging, the center said in a statement. The program uses in silico proficiency testing to evaluate the competency of hereditary or germline disease tests, along with solid or liquid tumor profiling tests. For payors, the program's metrics can provide evaluations when contracting with laboratories. For labs, the program provides a third-party review that can improve the accuracy of test findings.
The Prostate Cancer Foundation this week said it would contribute $2.5 million to launch the Drew Foundation Precision Oncology Center of Excellence in partnership with the University of California, San Francisco and the San Francisco VA Health Care System, or SFVAHCS. Through this new center, the partners hope to make precision oncology treatments more accessible to veterans with prostate cancer. More than 15,000 men are diagnosed with prostate cancer each year, and 500,000 men within the Veterans Affairs health system have the disease. UCSF researchers were codevelopers of Gallium 68 PSMA-11, the first US Food and Drug Administration-approved drug for PET-imaging of PSMA-positive lesions in men with prostate cancer. "The team of UCSF physician scientists involved with the new Drew Foundation Precision Oncology Center of Excellence at the SFVAHCS are leaders in the field and will contribute even more to our use of precision medicine to treat prostate cancer," Alan Ashworth, president of the UCSF Helen Diller Family Comprehensive Cancer Center, said in a statement.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.