The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of their BRCA mutation status. This indication also includes patients with advanced fallopian tube or primary peritoneal cancer. The decision comes two months after FDA’s acceptance of a supplemental New Drug Application (sNDA), which…
Conditions
Conditions
Large Study Finds No Evidence That Low-dose Aspirin Reduces Alzheimer’s Risk
Taking daily low-dose aspirin does not seem to reduce the risk of dementia, cognitive decline, or Alzheimer’s disease, new clinical trial data show. The results were published in Neurology in a study, titled “Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline.” Aspirin is a widely-used anti-inflammatory medication. Among its uses, low-dose daily…
Cirmtuzumab-Imbruvica Yields ‘Encouraging’ Response Rates Against Mantle Cell Lymphoma, Ongoing Trial Shows
Combination therapy with the investigational treatment cirmtuzumab plus Imbruvica (ibrutinib) led to “highly encouraging” response rates among patients with mantle cell lymphoma (MCL), a type of B-cell cancer, according to the latest clinical results announced by Oncternal Therapeutics. Cirmtuzumab, developed by Oncternal, is an investigational antibody that blocks ROR1, or receptor tyrosine kinase-like orphan receptor 1.…
Actemra May Treat Severe COVID-19 Infections in Myeloma Patients, Case Report Suggests
Actemra (tocilizumab), a medicine approved for certain types of arthritis, may be effective in treating severe infections with the new coronavirus in people with multiple myeloma or other blood disorders, findings from a patient in China suggest. The case report also indicates that those with blood cancers may have atypical COVID-19 symptoms, like an absence…
Dostarlimab Shows Promise for Advanced Endometrial Cancer, Early Trial Results Show
A subset of women with recurrent or advanced endometrial cancer, whose disease progressed on or after platinum-based chemotherapy, achieved clinically meaningful responses after treatment with dostarlimab, results of a Phase 1 clinical trial show. The findings, “Safety and efficacy of the anti–PD-1 monoclonal antibody dostarlimab in patients with recurrent or advanced dMMR endometrial cancer,” were…
FDA Approves Darzalex Faspro as Injection Therapy for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved Janssen‘s new formulation of daratumumab — a subcutaneous or under-the-skin injection treatment called Darzalex Faspro (daratumumab and hyaluronidase) — as a faster and easier alternative for people with multiple myeloma. The original formulation, Darzalex, requires an intravenous (into-the-vein) infusion given over several hours. Darzalex Faspro is seen to be an equally…
STRO-002 Continues to Show Promise in Advanced Ovarian Cancer, Early Trial Results Show
STRO-002, an investigational antibody-drug conjugate, continues to show promising safety and anti-tumor activity in women with advanced ovarian cancer, according to preliminary data from a Phase 1 clinical trial. The findings were presented by Wendel Naumann, MD, principal investigator of the trial, in a recent virtual presentation at the American Association for Cancer Research (AACR)…
FDA Approves Tukysa for Advanced HER2-positive Breast Cancer
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…
Yervoy Can Benefit Certain mCRPC Patients with Few Mutations in Tumors, Trial Finds
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 —…
Potential Agitation Treatment, AXS-05, Shows Efficacy and Safety in Phase 2/3 Trial
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…
FDA Decision on Liso-cel, CAR T-cell Therapy for Large B-cell Lymphoma, Due in November
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…
Cell Protein Analysis May Predict Multiple Myeloma Response to Treatment
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…