Adding Xtandi (enzalutamide) to standard androgen deprivation therapy (ADT) significantly prolonged life by nearly a year for men with high-risk, non-metastatic castration-resistant prostate cancer (CRPC), final data from a Phase 3 clinical trial show. The results, “Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer,” were published in the New England Journal of Medicine and presented…
Conditions
Conditions
FDA Approves Opdivo for Advanced Esophageal Cancer
The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of people with advanced, inoperable, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) previously treated with fluoropyrimidine– and platinum-based chemotherapy. The approval came after the regulatory agency granted priority review to the application. It was based on data from the ATTRACTION-3 Phase…
Xpovio Triple Combo Before FDA for Previously Treated Myeloma Patients
Karyopharm Therapeutics is asking that Xpovio (selinexor) be approved with Velcade (bortezomib) and low-dose dexamethasone to treat people with multiple myeloma after at least one line of therapy. The request was submitted to the U.S. Food and Drug Administration (FDA) in the form of a supplemental new drug application (sNDA). It is based on new data…
Neurotrope Launches Long-term Trial of Bryostatin-1
Neurotrope has announced the launch of a Phase 2 clinical trial to investigate the long-term use of bryostatin-1 for moderate and moderately severe Alzheimer’s disease. The company expects to dose the first patient later this year. “We are very excited to advance Bryostatin-1 to its next phase of development,” Daniel Alkon, MD, president and chief…
Ibrance Plus Endrocrine Therapy Unlikely to Stop Cancer Spread, Committee Says
An independent data monitoring committee (DMC) has deemed it unlikely that a combination of endocrine therapy and Pfizer’s Ibrance (palbociclib) will show benefits over standard therapy at delaying or preventing cancer spread in patients with early breast cancer. The ongoing Phase 3 PALLAS trial had been testing the efficacy of adding Ibrance to conventional endocrine…
Cancer Vaccine Plus Adoptive T-cell Therapy Placed on Fast Track
TVI-Brain-1, an immunotherapy being developed by TVAX Biomedical, was given fast track designation by the U.S. Food and Drug Administration (FDA) as a potential treatment of glioblastoma multiforme, a deadly form of brain cancer. A therapy candidate is named to the fast track program if it might treat serious conditions with unmet clinical need, either because no…
UK’s NICE Issues Draft ‘No’ Decision for Sarclisa Triple Combo
The U.K.’s National Institute for Health and Care Excellence (NICE) has issued a draft “no” statement on the triple combination of Sarclisa (isatuximab), Pomalyst (pomalidomide) and dexamethasone as a treatment for people with relapsed or refractory multiple myeloma. This draft decision means that, at present, NICE will not recommend to the United Kingdom’s National Health Service (NHS) that the triple…
DPX-Survivac Shows Durable Responses in Advanced Ovarian Cancers, Trial Data Show
A combination of IMV‘s immunotherapy DPX-Survivac plus intermittent low-dose cyclophosphamide leads to sustained responses in women with heavily-treated advanced ovarian cancer, with some responses lasting more than 10 months, updated findings from a Phase 1/2 clinical trial show. “We believe these results highlight DPX-Survivac’s potential to alter the treatment landscape in advanced ovarian cancer and…
Cancer DNA Levels in Blood Can Predict Treatment Responses
Analyses of circulating tumor DNA (ctDNA) — DNA from cancer cells circulating in the bloodstream — in blood samples can be used to predict which men with advanced prostate cancer are more likely to respond to treatment and who is more likely to have the disease return later on. The new, non-invasive test is less…
Anavex 2-73 Trial for Early Alzheimer’s Expanded to Canada, UK
Anavex Life Sciences will expand its Phase 2b/3 clinical trial testing the efficacy and safety of Anavex 2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and the United Kingdom (U.K.) following the go-ahead from Health Canada and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). The clinical trial, dubbed Anavex 2-73-AD-004…
Bavencio Shows Benefit as 1st-line Maintenance Therapy for Bladder Cancer in Phase 3 Trial
First-line maintenance therapy with Bavencio (avelumab) significantly delays disease progression or death in people with inoperable, locally advanced or metastatic urothelial carcinoma, a common type of bladder cancer, according to interim data from a Phase 3 trial. This survival benefit was observed regardless of the levels of the PD-L1 protein in cancer cells (the therapy’s target), highlighting that…
Phase 3 Trial of Melflufen Combo in Advanced Multiple Myeloma Fully Enrolled
A pivotal Phase 3 study investigating melflufen (melphalan flufenamide) plus dexamethasone in people with relapsed or refractory multiple myeloma is fully enrolled, Oncopeptides, the treatment’s developer, announced. The OCEAN trial (NCT03151811) recruited 450 patients across more than 100 clinical sites worldwide, and top-line results are expected later this year. “I am very pleased to announce that we…