Over some four weeks, 1,066 people with multiple myeloma took part in a survey sponsored by HealthTree to better understand how COVID-19 is affecting life for those with this blood cancer. The survey, announced on April 16, aims to provide patients and physicians with information that will help guide future healthcare decisions. It assesses myeloma patient vulnerability, and…
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as a first-line therapy for people with inoperable or metastatic colorectal cancer with specific genetic features that denote a high mutation rate. The decision comes after promising findings from KEYNOTE-177 (NCT02563002), a Phase 3 trial in which Keytruda more than doubled the time patients lived…
The U.S. Food and Drug Administration (FDA) has approved Phesgo, an under-the-skin injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, as a faster and more convenient alternative to treat people with HER2-positive breast cancer. The approval of this fixed-dose combination is for use with chemotherapy in early and metastatic breast cancers, the same indications for which the…
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…
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…
