Treatment with sumifilam significantly lowered the levels of multiple biomarkers of disease activity, neurodegeneration, and inflammation in people with mild-to-moderate Alzheimer’s after 28 days of treatment, according to final data from a Phase 2b trial. Sumifilam, Cassava Sciences’ lead investigational candidate for Alzheimer’s disease, also was found to be safe and well-tolerated, and to improve…
Conditions
Conditions
EU Approval Recommended for Opdivo-Yervoy-Chemo Combo for Advanced NSCLC
A European Medicines Agency (EMA) committee has recommended that a combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy be approved in the European Union (EU) as first-line treatment for advanced non-small cell lung cancer (NSCLC). The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval specifically for adults whose tumors contain no mutations in the…
Ide-cel Granted FDA Priority Review for Heavily-treated Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb and Bluebird Bio‘s application requesting the approval of idecabtagene vicleucel (ide-cel) for the treatment of adults with multiple myeloma. The biologics license application (BLA), resubmitted in August, is seeking ide-cel’s approval for myeloma patients who failed to respond to at least three prior lines…
Clinical Trial Testing Estrogen Receptor Degrader GDC-9545 Enrolls First Participant
The first participant has been enrolled in a Phase 2 clinical trial evaluating the safety and efficacy of GDC-9545 in combination with palbociclib as an investigational treatment for postmenopausal women with estrogen receptor (ER)-positive and HER2-negative untreated early breast cancer. “The initiation of enrolment is an important milestone as we aim to better understand the activity and safety of this…
Lynparza Combo Recommended by EU Committee as First-line Maintenance for Advanced Ovarian Cancer
Lynparza (olaparib), in combination with bevacizumab, has been recommended for approval in the European Union (EU) as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. The positive opinion released by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, also includes…
Phase 1 Trial of Oral Treatment for Metastatic CRPC Doses First Patient
A first patient has been dosed in a Phase 1 clinical trial investigating the small molecule inhibitor EPI-7386 as a treatment for metastatic castration-resistant prostate cancer (CRPC), its developer, ESSA Pharma, reported. Metastatic CRPC is prostate cancer that has metastasized, or spread to distant regions, and is resistant to traditional treatments that lower levels of androgen hormones,…
Tecentriq-Avastin Combo Recommended for EU Approval for Liver Cancer
Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), has been recommended for approval in the European Union as a first-line treatment for adults with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency. The…
Ninlaro Combo Fails to Halt Progression of Newly Diagnosed Multiple Myeloma, Trial Data Show
Adding Takeda’s Ninlaro (ixazomib) to Revlimid (lenalidomide) and dexamethasone failed to significantly extend life without disease progression in people newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant, top-line data from a Phase 3 clinical trial show. Still, Ninlaro’s triple combination was significantly superior to the Revlimid-dexamethasone combo at promoting profound treatment…
CDC Taps Alzheimer’s Association to Lead National Effort to Slash Dementia Risk
The Alzheimer’s Association has been chosen to lead a national public health effort aimed at lowering the risk of cognitive decline and dementia. The organization was selected by the Centers for Disease Control and Prevention (CDC) as a Building Our Largest Dementia (BOLD) Public Health Center of Excellence (PHCOE) for dementia risk reduction. To fund…
Verzenio With Endocrine Therapy Can Lower Risk of Recurrence, Spread in Early Breast Cancer, Trial Shows
When given alongside endocrine therapy (ET), Verzenio (abemaciclib) can lower the risk of cancer recurrence and spread compared to standard ET alone in patients with certain forms of early breast cancer who have a high risk of seeing their disease return and spread elsewhere, according to results from a Phase 3 trial. Data from the study’s…
ONCOTracker, Binding Site Team Up to Develop sBCMA Monitoring Test
ONCOTracker and The Binding Site have entered an agreement to develop and commercialize a new test that measures serum levels of the B-cell maturation antigen (sBCMA) protein to monitor people with blood cancers, including multiple myeloma. Under the agreement, The Binding Site has gained exclusive rights to commercialize this test worldwide. ONCOTracker, which has patented…
STRO-002 Trial Update Supports Its Safety, Activity in Advanced Cancer
Updated interim data from a Phase 1 clinical trial continues to support the safety and anti-tumor activity of Sutro Biopharma’s STRO-002 for heavily pre-treated women with advanced ovarian cancer. About one-quarter of patients receiving a dose of 2.9 mg/kg or higher responded to this investigational antibody-drug conjugate, and nearly half (44%) had responses lasting at least 16 weeks, results showed.…