An advisory arm of the U.S. Food and Drug Administration (FDA) is recommending that available clinical data on aducanumab (BIIB037) does not support the effectiveness of this investigational therapy in treating Alzheimer’s disease. In votes, eight of the committee’s 11 members found Phase 3 EMERGE data did not provide “strong evidence” of efficacy, and seven members…
The European Commission has approved Lynparza (olaparib) to treat people with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in the DNA repair genes BRCA1 and BRCA2. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency. “This approval in the EU is a landmark…
The European Commission has approved Lynparza (olaparib), in combination with bevacizumab, 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. This indication also includes patients with advanced fallopian tube cancer or primary peritoneal cancer. Eligible HRD-positive tumors are those carrying mutations in…
The European Medicines Agency (EMA) has agreed to review Biogen and Eisai’s application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The companies’ approval request — in the form of a marketing authorization application (MAA) — will be analyzed by the EMA following the usual review timetable for new medications, which can…
SpringWorks Therapeutics announced new collaborations with two companies, Pfizer and Janssen, to investigate its oral therapy candidate nirogacestat in combination with BCMA-targeting agents to treat people with relapsed or refractory multiple myeloma. The collaboration with Pfizer aims to test nirogacestat plus PF‐06863135 in a Phase 1b/2 trial, while SpringWorks and Janssen will launch a Phase 1 trial investigating…
The European Commission has approved a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) that contain no mutations in the EGFR or ALK genes. The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use, a…
A new Athenex Oncology guide offers evidence-based lifestyle suggestions to metastatic breast cancer (MBC) patients to help improve their quality of life. The free booklet, called “Your Guide to Facing Metastatic Breast Cancer,” is touted as a first-of-its-kind resource. Its recommendations include building physical and emotional resilience, maintaining a healthful diet, getting enough sleep, lowering…
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CellProtect, an investigational therapy for multiple myeloma that uses a person’s immune cells to help combat cancer. This designation is given to therapies with the potential to improve medical care for rare disorders, defined as those that affect fewer than 200,000 people…
The European Commission has approved the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) as a first-line treatment for adults with advanced or inoperable hepatocellular carcinoma (HCC), the most common form of liver cancer. This decision follows the recommendation of the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA). The Tecentriq-Avastin…
A Phase 1 trial evaluating Poseida Therapeutics’ autologous CAR T-cell therapy P-PSMA-101 for metastatic castration-resistant prostate cancer (mCRPC) is resuming immediately, after its clinical hold was lifted. The U.S. Food and Drug Administration (FDA) had placed a partial hold on the trial in August, after a patient died of liver failure a few weeks after…
