Adding Erleada (apalutamide) to androgen deprivation therapy (ADT) significantly extends the lives of men with non-metastatic castration-resistant prostate cancer (CRPC) by more than one year, a final analysis of the SPARTAN Phase 3 clinical trial shows. Representing a 22% reduction in the risk of death in men at high risk of developing metastasis, the findings add…
The Swiss Agency for Therapeutic Products (Swissmedic) has approved Seattle Genetics‘ Tukysa, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with metastatic HER2-positive breast cancer. Tukysa is now approved for individuals who have been treated previously with at least two other anti-HER2 therapies, examples of which include Kadcycla (ado-trastuzumab emtansine), Perjeta (pertuzumab), and trastuzumab (sold under the brand name Herceptin,…
Zejula (niraparib) given in combination with Avastin (bevacizumab) shows promising safety and efficacy at delaying disease progression in women with advanced ovarian cancer who had responded to a first-line platinum-based chemotherapy plus Avastin, interim results from a Phase 2 trial show. These findings are in the presentation, “Phase II OVARIO study of niraparib + bevacizumab therapy…
The U.S. Food and Drug Administration (FDA) has approved Lynparza (olaparib), in combination with bevacizumab, as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. This indication also includes patients who have advanced fallopian tube or primary peritoneal cancer. HRD-positive tumors — present in one of every two women with advanced ovarian…
A potential CAR T-cell therapy by Innovative Cellular Therapeutics (ICT) showed early signs of safety and efficacy, significantly reducing tumor size in four patients with thyroid or colorectal cancer, new data show. These findings will be shared in two presentations this Friday, May 15, at the ongoing 23rd American Society of Gene & Cell Therapy Annual…
A new technology that measures the levels of proteins in individual cells could help to identify therapy combinations that might more effectively treat people with multiple myeloma, a study suggests. Its researchers also report that lowering levels of a particular protein on myeloma cells, MCL-1, may make them more responsive to treatments for this cancer. The…
The U.S. Food and Drug Administration (FDA) has extended by three months its review of Bristol-Myers Squibb’s investigational CAR T-cell therapy, lisocabtagene maraleucel (liso-cel), as a treatment for adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, the company announced. Liso-cel’s new Prescription Drug User Fee Act (PDUFA) action date is now Nov. 16, 2020, instead of August…
Axsome Therapeutics‘ investigational oral therapy AXS-05 significantly and rapidly lessened agitation in patients with Alzheimer’s disease, top-line results from a Phase 2/3 trial show. The therapy was also found to be generally well-tolerated and safe, without affecting cognition. “I am very pleased to see the promising results of the ADVANCE-1 trial, providing clear evidence of reduced agitation…
Men with metastatic castration-resistant prostate cancer (mCRPC) showing evidence of active immune responses in their tumors live longer without disease progression after being treated with Yervoy (ipilimumab), a Phase 2 trial shows. These findings demonstrate that a subset of men with this form of advanced prostate cancer may benefit from treatment with immune checkpoint inhibitors —…
Seattle Genetics’ Tukysa (tucatinib) can now be used in combination with trastuzumab and Xeloda (capecitabine) to treat people with metastatic or inoperable HER2-positive breast cancer following its approval by the U.S. Food and Drug Administration (FDA). This will help patients with or without brain metastases who have received one or more prior treatments with HER2-targeted…
