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Groups Pledge Funding for Project to Develop Ovarian Cancer Blood Test

Groups Pledge Funding for Project to Develop Ovarian Cancer Blood Test

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…

Relugolix Granted FDA Priority Review as New Treatment Type

Relugolix Granted FDA Priority Review as New Treatment Type

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…

FDA Approves Keytruda for Advanced Squamous Cell Skin Cancer

FDA Approves Keytruda for Advanced Squamous Cell Skin Cancer

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…

Oncopeptides Reports Positive Results from HORIZON Trial of Melflufen Combo

Oncopeptides Reports Positive Results from HORIZON Trial of Melflufen Combo

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…

Investigational Agitation Treatment AXS-05 Named FDA Breakthrough Therapy

Investigational Agitation Treatment AXS-05 Named FDA Breakthrough Therapy

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Axsome Therapeutics‘ AXS-05, an investigational oral therapy for the treatment of agitation in people with Alzheimer’s disease. This designation is intended to accelerate the development and review of potential therapies for serious diseases. It is awarded upon clinical evidence of substantial improvement…

Cancer Vaccine Combo to be Tested in Triple Negative Breast Cancer

Cancer Vaccine Combo to be Tested in Triple Negative Breast Cancer

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…

EMA Asked to Conditionally Approve Gliovac, Cancer Vaccine, for Recurrent Glioblastoma

EMA Asked to Conditionally Approve Gliovac, Cancer Vaccine, for Recurrent Glioblastoma

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…

Ninlaro Maintenance Therapy Improves Survival in Patients Not Given ASCT, Trial Shows

Ninlaro Maintenance Therapy Improves Survival in Patients Not Given ASCT, Trial Shows

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…

FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials

FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials

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…

Second Surgery May Aid Survival in Recurrent Ovarian Cancer, Study Finds

Second Surgery May Aid Survival in Recurrent Ovarian Cancer, Study Finds

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…

Ipatasertib Combo Fares Well in Early Results of IPATential150 Phase 3 Study

Ipatasertib Combo Fares Well in Early Results of IPATential150 Phase 3 Study

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…

Amylyx Completes Enrollment in PEGASUS Trial of AMX0035 for Alzheimer’s

Amylyx Completes Enrollment in PEGASUS Trial of AMX0035 for Alzheimer’s

Amylyx Pharmaceuticals announced it has completed enrollment for the Phase 2 clinical trial of AMX0035 for treating Alzheimer’s disease. The placebo-controlled trial, PEGASUS (NCT03533257), will evaluate the compound’s safety and tolerability among patients with late mild cognitive impairment or early dementia due to Alzheimer’s disease. Other study endpoints (goals) include the compound’s effects on Alzheimer’s biomarkers (methods…