Adding ipatasertib to standard treatment for metastatic castration-resistant prostate cancer (mCRPC) significantly extended survival without disease worsening in a group of men whose tumors lack the PTEN protein, a Phase 3 clinical trial found. But the combination, which included ipatasertib plus standard Zytiga (abiraterone acetate) and prednisone/prednisolone, failed to extend the time without disease progression or death…
Woman whose ovarian cancer returns more than six months after initial surgery and chemotherapy may benefit from a second surgery, but only if the entire tumor is removed during the procedure, data from a clinical trial show. Patients should be carefully selected for a second surgery, based on the likelihood that this surgery will successfully remove…
The U.S. Food and Drug Administration (FDA) has launched an initiative called Project Patient Voice to create a publicly available information bank describing patient-reported symptoms from cancer trials for marketed treatments. The initiative is a part of the FDA’s Oncology Center of Excellence (OCE), which is designed to advance the development and regulation of oncology…
First-line maintenance therapy with Ninlaro (ixazomib) significantly delays disease progression or death in adults with multiple myeloma who had not been initially treated with an autologous stem cell transplant (ASCT), according to data from a Phase 3 trial. “There is a strong need for additional maintenance treatments for multiple myeloma, where currently approved options are limited,” Meletios…
ERC Belgium has asked the European Medicines Agency (EMA) to give conditional approval to its investigational anti-cancer vaccine Gliovac (ERC1671) for the treatment of recurrent glioblastoma, an aggressive form of brain cancer. Gliovac, which the company also refers to as Sitoiganap, is an advanced form of immunotherapy made up of cancer cells and other tumoral components freshly…
UbiVac and Bristol Myers Squibb have announced plans to collaborate on a clinical trial to test whether a combination therapy approach can boost cancer immunity in patients with advanced triple negative breast cancer. The Phase 1b trial will evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product, DPV-001, in combination with Bristol Myers Squibb’s…
The combination therapy of melflufen (melphalan flufenamide) and dexamethasone continues to be safe and to elicit deep and durable responses in hard-to-treat patients with relapsed or refractory multiple myeloma, top-line data from a Phase 2 clinical trial shows. The findings will support Oncopeptides‘ submission of a new drug application requesting accelerated approval of melflufen for treating relapsed…
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as a treatment for people with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) — the second most common form of skin cancer — that is not curable by surgery or radiation therapy. The decision was based on data from a Phase 2 trial called…
The U.S. Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) Myovant Sciences submitted earlier this year requesting the approval of relugolix for the treatment of men with advanced prostate cancer. The priority review status will shorten relugolix’s regulatory review for this indication from the standard 10 months to…
A team at Griffith University’s Institute for Glycomics in Australia has received $300,000 in funding from The Bourne Foundation, as well as a further funding pledge from Tour de Cure, to advance research into the development of blood tests for the early diagnosis of ovarian cancer. “Despite decades of research, there is currently no easily accessible, non-invasive and…
