First-line maintenance therapy with Darzalex (daratumumab) significantly delays disease progression or death in adults with multiple myeloma who responded to autologous stem cell transplant (ASCT), according to data from the CASSIOPEIA trial’s second part. These findings, from a pre-planned interim analysis conducted by an independent data monitoring committee, indicate that the Phase 3 trial met the main goals of both its…
The U.S. Food and Drug Administration (FDA) has agreed to review applications requesting the approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for people with advanced renal cell cancer, the most common type of kidney cancer in adults. The applications — requests to extend the indications for Opdivo by Bristol Myers Squibb and Cabometyx by Exelixi — were given priority…
A simple language test, when combined with an artificial intelligence model, can predict which people will develop Alzheimer’s disease later in life, a study shows. This new model predicted Alzheimer’s seven years before its diagnosis with an accuracy of 70%, according to the study. That rate is higher than those attained by traditional predictive methods,…
Oncopeptides soon will seek conditional approval of melflufen (melphalan flufenamide) in the EU for the treatment of relapsed or refractory multiple myeloma. The pharmaceutical company now is planning to submit its application — some two years earlier than expected — to the European Medicines Agency (EMA) to request melflufen’s conditional approval. The request was originally intended to…
Adding UV1, Ultimovacs’ experimental cancer vaccine, to Keytruda (pembrolizumab) is safe and shows initial signs of effectiveness in adults with previously untreated metastatic melanoma, according to top-line data from a Phase 1 clinical trial. “The safety profile observed to date in this first cohort [group of patients] of the [UV1-Keytruda] combination study is consistent with the promising…
Adding four months of androgen deprivation therapy (ADT) to radiation treatment extends survival and delays metastasis in men with unfavorable intermediate-risk prostate cancer, according to a secondary analysis of a Phase 3 clinical trial. However, that new trial analysis showed there were no such benefits to ADT therapy for men with favorable intermediate-risk prostate cancer undergoing…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to PC14586 as a potential treatment of advanced cancers that harbor a specific mutation affecting the protein p53, which includes some ovarian cancers. Fast track is given to support therapies with the potential to fill a serious unmet medical need. They are eligible…
Delays in breast cancer surgery due to the COVID-19 pandemic could cost 2,797 additional deaths in the U.S. over the next decade, according to a Kantar Health analysis. Such treatment delays also place patients at a higher risk of metastasis, or cancer spread, potentially increasing healthcare costs in the U.S. by an estimated $376 million…
After first rejecting a Sarclisa (isatuximab) triple combination therapy due to cost-effectiveness concerns, the U.K.’s National Institute for Health and Care Excellence (NICE) has given conditional approval to the treatment for relapsed or refractory multiple myeloma. The triple therapy includes Sarclisa in combination with Imnovid (pomalidomide, also sold as Pomalyst) and dexamethasone, a corticosteroid. It is particularly recommended for…
A committee of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of people with advanced, inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who previously received a chemo regimen containing fluoropyrimidine and a platinum agent. The European Commission will review this opinion from the Committee for Medicinal Products for Human…
