FDA has granted accelerated approval to the combination of Merck's Keytruda (pembrolizumab) plus Esai's Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
FDA has approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Nearly half of phase III cancer clinical trials carried out by the NCI-sponsored SWOG Cancer Research Network were associated with clinical care guidelines or new drug approvals.
Invitae, a medical genetics company, announced the availability of a testing program, Detect Hereditary Pancreatic Cancer, that offers no-charge genetic testing and counseling to patients with pancreatic cancer.
Adaptimmune Therapeutics plc said FDA has granted Orphan Drug Designation to SPEAR T-cells targeting MAGE-A4 (Adaptimmune's ADP-A2M4 program) for the treatment of soft tissue sarcomas.
BioXcel Therapeutics Inc. said FDA has granted Orphan Drug Designation for BXCL701, an investigational orally-available systemic innate immunity activator with dual mechanisms of action, for the treatment of acute myeloid leukemia.
FDA has granted an accelerated approval to Rozlytrek (entrectinib) for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
Syapse and the FDA Oncology Center of Excellence signed a multi-year Research Collaboration Agreement focused on the use of real-world evidence to support regulatory decision-making.
FDA has granted Breakthrough Therapy Designation for Calquence (acalabrutinib) as a monotherapy for adult patients with chronic lymphocytic leukemia.
The European Commission has approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.
