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.
Circuit Clinical announced a collaboration with Roswell Park Comprehensive Cancer Center to support the expansion of clinical trial opportunities to its outpatient oncology practices. This collaboration marks Circuit Clinical's entry into oncology clinical research, with both digital and clinical services.
FDA 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.
AstraZeneca and Merck announced the European Commission has approved Lynparza as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, and who have HER2-negative locally advanced or metastatic breast cancer.
FDA has approved a labeling change for Soltamox (tamoxifen citrate, oral solution), reverting to two months of contraception following cessation of tamoxifen.
Some patients who died within one month of being newly diagnosed with metastatic cancer in the United States received ineffective surgery, chemotherapy, radiation, and hormonal therapy according to a new American Cancer Society study.
