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…
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…
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…
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…
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…
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,…
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…
Cerecor has dosed the first patient in a Phase 1b clinical trial evaluating CERC-007 as a potential treatment for relapsed or refractory multiple myeloma. The trial (NCT04671251) intends to enroll up to 30 adult patients who received prior treatment with a proteasome inhibitor, an immunomodulatory agent, and a CD38 inhibitor. Recruitment is ongoing at four…
The European Commission has approved Keytruda (pembrolizumab) as a first-line therapy for adults with metastatic colorectal cancer whose tumors have certain genetic features, the company announced. The genetic features, according to a press release, include microsatellite instability-high (MSI-H) and deficient mismatch repair (dMMR), both good indicators that tumor cells have impaired DNA repair. These DNA repair deficiencies contribute…
CRY-1, a regulator of our circadian clocks, contributes to disease spread and poor outcomes in prostate cancer patients by boosting DNA repair mechanisms that render cells more resistant to treatments, a study reveals. The findings support further investigation of CRY-1 as a therapeutic target, especially in prostate cancers that fail to respond to current therapies. The…
