The U.S. Food and Drug Administration (FDA) has accepted to review two new Merck applications requesting the approval of Keytruda (pembrolizumab) for the treatment of patients with different forms of triple-negative breast cancer (TNBC). One of the two supplemental biologics license applications (sBLAs) was granted priority review, which speeds FDA action, with a Prescription Drug User…
Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. According to a press release, the BLA now includes further details on the CAR T-cell therapy’s chemistry, manufacturing, and control — a module necessary to…
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Blenrep (belantamab mafodotin-blmf), a first-in-class treatment for heavily pretreated adults with relapsed or refractory multiple myeloma, its developer, GlaxoSmithKline, announced. The approval is specific for people who have been given at least four previous therapies, including a CD38 inhibitor, a proteasome inhibitor, and an immunomodulatory…
Fate Therapeutics will soon initiate a Phase 1 trial investigating its CAR T-cell therapy, FT819, across several B-cell cancers, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin’s lymphoma (NHL). The announcement follows the clearance of Fate’s investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial will…
The addition of Tecentriq (atezolizumab) to first-line treatment with Avastin (bevacizumab) and chemotherapy does not significantly extend survival without disease worsening in people with newly-diagnosed advanced ovarian cancer, a recent trial shows. While the IMagyn050 Phase 3 trial (NCT03038100) failed to meet one of its primary endpoints, researchers are gathering more data to determine whether…
A research collaboration led by the Hudson Institute of Medical Research as been awarded a $2.2-million grant to advance knowledge about ovarian granulosa cell tumors (GCT) and ultimately improve the outcomes of patients with this rare form of ovarian cancer. The multi-faceted research project will focus on mapping genetic mutations in GCTs, as well as…
An ongoing observational registry study is evaluating Kiyatec‘s novel technology, in which a patient’s own tumor tissue is cultured in a lab dish and exposed to different therapies as a means to predict treatment response in women with ovarian cancer. The 3D-PREDICT trial (NCT03561207) is studying the company’s patient-specific Ex Vivo 3D Cell Culture (EV3D)…
Image-guided laser focal therapy is as effective as radical prostate removal surgery at treating men with localized prostate cancer, without the added risks of infection, incontinence, and erectile dysfunction, according to 10-year interim data from a Phase 2 trial. The trial findings were slated to be presented in a poster, “Outpatient Trans-Rectal MR-Guided Laser Focal…
The University of Colorado Anschutz Medical Campus, led by CU Innovations, has partnered with medical technology entrepreneurs Jonathan Gasson and Sharon Lake to form a new company called PreView Medical, which will focus on the development and optimization of new diagnostic procedures and treatments for prostate cancer. PreView Medical’s ClariCore System is based on a…
YourVaccx, a new type of cancer vaccine developed by ImmunSYS, is safe and shows promising effectiveness in patients with metastatic prostate cancer and other difficult-to-treat advanced solid tumors, a proof-of-concept study shows. Study findings were presented in a poster titled, “Regression of metastatic cancer and abscopal effects following in situ vaccination by cryosurgical tumor cell…
