BioVaxys is planning to request that its investigational vaccine for ovarian cancer, BVX-0918A, be approved for compassionate use in people with advanced ovarian cancer in Europe. The company also plans to file requests to U.S. and European regulatory health authorities requesting authorization to pursue clinical trials of BVX-0918A in the coming months. As part of…
Conditions
Conditions
EU Committee Supports Nexpovio for Heavily Treated Myeloma Patients
A combination of Nexpovio (selinexor) and the corticosteroid dexamethasone has been recommended for conditional approval in the European Union to treat adults with relapsed or refractory multiple myeloma who received at least four prior therapies. This includes patients whose disease failed to respond to at least two proteasome inhibitors, two immunomodulatory agents, and a CD38 inhibitor,…
FDA Extends Its Aducanumab Review with Decision Expected in June
The U.S. Food and Drug Administration (FDA) has extended its review period for aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease being co-developed by Biogen and Eisai. The three-month extension means the new deadline to review the compound’s biologics license application (BLA), also known as the Prescription Drug User Fee Act action date, is June…
US Study Enrolling Women to Help Determine Best Screening Practices
A national study is seeking women in the U.S. to help determine the safest and best way to screen for breast cancer, and to improve on current guidelines. It’s being conducted at several sites across the country with the aim of enrolling 100,000 women, 40 to 74 years of age, who have not been diagnosed…
First Glioblastoma Patient Dosed in Phase 2 Trial Testing PVSRIPO Plus Keytruda
The first patient has been dosed in a Phase 2 trial assessing the safety and preliminary efficacy of PVSRIPO in combination with Keytruda (pembrolizumab) as a treatment for people with recurrent glioblastoma multiforme (rGBM), an aggressive form of brain cancer. The open-label study, called LUMINOS-101 (NCT04479241), aims to enroll around 30 adults with rGBM from several…
NBA Teams Join Efforts to Raise Money and Awareness
The Prostate Cancer Foundation (PCF) and several NBA teams are joining efforts to raise money and awareness for prostate cancer research throughout February. Various national basketball teams, including the Atlanta Hawks, Chicago Bulls, and Phoenix Suns, are taking part in the Third Annual PCF Black History Month Assist Challenge. “We are thrilled and honored that…
Troriluzole Fails to Ease Cognitive Impairments in Phase 2/3 Trial
Troriluzole, an investigational oral symptomatic treatment developed by Biohaven for Alzheimer’s disease, did not work better than a placebo in alleviating cognitive impairments and reducing brain volume loss in patients with mild-to-moderate disease, according to top-line data from a Phase 2/3 trial. However, a subgroup analysis — performed in the subset of study patients with…
Keytruda Closer to Expanded EU Approval for Resistant Hodgkin’s Lymphoma
Keytruda (pembrolizumab) has been recommended for approval in the European Union (EU) to treat adults and children, 3 years and older, with relapsed or refractory classical Hodgkin’s lymphoma (cHL) whose disease failed to respond to autologous stem cell transplant (ASCT) or who received at least two prior therapies when ineligible for ASCT. The therapy is…
EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma
An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients, its developer, Janssen, announced. An accelerated assessment, given to medications expected to have a major impact on public health, shortens the regulatory review process in Europe to 150 days from the…
Blocking Glutamine Metabolism May Help Combat OCCC Tumors
Ovarian cancer cells harboring mutations in the ARID1A tumor suppressor gene tend to use the amino acid glutamine as a source of energy more often, making the cells more vulnerable to compounds that interfere with glutamine metabolism, scientists found. As proof, they demonstrated that a compound that inactivates glutaminase (the enzyme that normally breaks down…
Theralink Begins Testing New Biomarker Assay for Breast Cancer Tumors
Theralink Technologies announced that it has begun testing its new profiling biomarker assay — a test that could potentially provide oncologists with key information about a patient’s specific tumor — in people with breast cancer. “The Theralink assay for breast cancer may reveal therapeutic options for oncologists and in turn, may provide better outcomes for…
Early Trial Starts Testing Recommended STRO-002 Dose for Advanced Cancer
Sutro Biopharma‘s Phase 1 clinical trial has begun testing the recommended dose of STRO-002 in heavily pretreated patients with advanced ovarian cancer. “We are excited to be part of the STRO-002-GM1 dose-expansion study and to provide additional clinical data to show the potential of this therapeutic for ovarian patients with limited treatment options,” Lainie Martin, MD,…