The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application to FDA seeking approval of a new indication for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer.
Caris Life Sciences said the company has been selected by the Hoosier Cancer Research Network and the study's sponsor investigator, Matthew Galsky, to perform genomic tumor profiling for a new phase II bladder cancer clinical trial, HCRN GU16-257. This marks the second tumor profiling study Caris has been selected to lead within the Hoosier Cancer Research Network.
FDA approved pembrolizumab plus axitinib (Keytruda) for the first-line treatment of patients with advanced renal cell carcinoma.
Janssen Pharmaceuticals said Balversa (erdafitinib) received accelerated approval from FDA for the treatment of adults with locally advanced or metastatic urothelial carcinoma which has susceptible fibroblast growth factor receptor 3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients' tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score ≥1%) determined by an FDA-approved test.
Aprea Therapeutics said FDA has granted Fast Track designation to APR-246 for the treatment of patients with MDS having a TP53 mutation. In addition, FDA has also granted Orphan Drug Designation to APR-246 for treatment of MDS.
Intensity Therapeutics Inc. said FDA has granted Fast Track designation to the company's development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer who have failed at least two prior lines of therapy.
Kitov Pharma Ltd. announced a milestone in the acquisition of FameWave Ltd., following signature of a clinical collaboration agreement between FameWave and Bristol Myers Squibb for their planned phase I/II clinical trials to evaluate the combination of CM-24, a monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 with nivolumab in patients with non-small cell lung cancer.
Notable and Stanford Medical Center announced the results of a new study on the feasibility of personalized medicine. The study's objective was to rapidly sequence MDS blood cancer samples; analyze each sample against hundreds of drugs and drug combinations; and make personalized treatment recommendations for each sample—all within a maximum of 30 days.
OncoSec Medical Inc. and Duke University School of Medicine said they have entered into a collaborative research agreement to evaluate the use of OncoSec's proprietary TAVOPLUS (enhanced IL-12 DNA-plasmid) in combination or sequence with a HER2-plasmid vaccine administered with OncoSec's novel intratumoral delivery system.
