Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the U.K. for the treatment of adults with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. A conditional approval is given to therapies whose benefit of immediate availability outweighs the risk of having less comprehensive data. Still, regulators require additional…

People with advanced multiple myeloma and diffuse large B-cell lymphoma (DLBCL) will soon be able to access Xpovio (selinexor) outside the U.S. through a managed access program. This program, also known as a named patient program, allows patients and doctors in countries where a medicine is not yet approved or available access to them, provided the medicine…

C4 Therapeutics is preparing to launch a clinical trial testing its lead investigational therapy CFT7455 in multiple myeloma and other blood cancers. The U.S. Food and Drug Administration (FDA) approved the company’s application requesting a Phase 1/2a trial, which could open by mid-year. “With FDA clearance achieved, we are on track to advance CFT7455 into…

Treatment with Opdivo (nivolumab) after surgery significantly delays disease recurrence or death in patients with muscle-invasive urothelial carcinoma, a form of bladder cancer that has spread to nearby muscles, according to data from a Phase 3 clinical trial. These beneficial effects were seen in the overall population of patients in the CheckMate-274 trial (NCT02632409), as…

Combining Erleada (apalutamide) and Zytiga (abiraterone acetate) to treat metastatic castration-resistant prostate cancer (mCRPC) significantly extends the time patients live without signs of disease worsening, compared with Zytiga alone, Janssen announced in a press release. Findings from the ACIS Phase 3 trial (NCT02257736), which enrolled patients on androgen deprivation therapy (ADT) who had not been treated with…

The hormone progesterone helps to drive the development of metastatic ovarian cancer, and blocking progesterone signaling may be a useful strategy for preventing the cancer, a study in mice suggests. The study, “Targeting progesterone signaling prevents metastatic ovarian cancer,” was published in PNAS. High-grade serous carcinoma (HGSC) is the most common, and most deadly, form of…

An open-label Phase 2 clinical trial will test the safety and efficacy of IRX-2, an experimental immunology-based cancer therapy, in combination with Keytruda (pembrolizumab) and chemotherapy. The study is enrolling adults with triple-negative breast cancer (TNBC) — cancers not driven by the hormones progesterone or estrogen, or by the protein HER2 — according to the…

People with blood type O are significantly less likely to develop multiple myeloma, but those who do are likely to have more aggressive disease and poorer survival outcomes, a study found. The study, “Effect of the ABO blood groups on the development, clinical features and survival of multiple myeloma,” was published in the journal Magazine…

FLX475, an investigational anti-cancer therapy by RAPT Therapeutics, is safe and shows promising anti-tumor clinical activity, both alone and in combination with Keytruda (pembrolizumab), in certain types of cancer. These are the preliminary findings of a global, open-label Phase 1/2 trial (NCT03674567), which is recruiting participants across 32 sites in the U.S., Australia, and Asia.…

When given in combination with androgen deprivation therapy or ADT, Erleada (apalutamide) significantly prolonged the lives of men with metastatic hormone-sensitive prostate cancer (mHSPC) — without compromising their quality of life — according to final data from a Phase 3 trial. Findings from the study, called TITAN (NCT02489318), also showed that the combination treatment significantly…

InVivo Analytics has received $1.7 million to develop and commercialize its next-generation fluorescence imaging device, called InVivoFLUOR, for 3D monitoring of immune cell migration in animal models of cancer, the company announced in a press release. Company researchers plan to validate the system on a mouse model of ovarian cancer. Animals will be treated with…

Adding Darzalex (daratumumab) to standard regimens for adults with relapsed or refractory multiple myeloma resulted in higher rates of deep and durable responses, according to exploratory analyses of two Phase 3 trials. These findings, from the ongoing POLLUX (NCT02076009) and CASTOR (NCT02136134) trials, were based on patients achieving and sustaining a status of minimal residual…