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…
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…
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…
Lynparza (olaparib) has been recommended for approval in the European Union to treat men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in BRCA1 and BRCA2, two DNA repair genes. The marketing authorization application is specific for men whose disease progressed after treatment that included a newer hormone therapy, such as Xtandi (enzalutamide) or Zytiga (abiraterone acetate). The positive opinion by the…
The Committee for Medicinal Products for Human Use (CHMP) has recommended Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy. This favorable opinion by the committee, a branch of the European Medicines Agency (EMA), is one of the final steps of Zejula’s marketing authorization procedure that may lead to…
A specific form of the tau protein, called phosphorylated-tau-217 or p-tau217, may function as a blood biomarker of Alzheimer’s disease, allow the development of blood tests to accurately diagnose the disease at earlier stages. These are the findings of three studies presented during the recent Alzheimer’s Association International Conference (AAIC) 2020. The brains of those with Alzheimer’s disease show…
The U.S. Food and Drug Administration has granted fast track designation to PBCAR269A, Precision BioSciences‘ donor-derived CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. Fast track status is meant to facilitate the development, and accelerate the review, of new medications that aim to treat serious conditions and fill an unmet medical need.…
The U.S. Food and Drug Administration (FDA) has designated toripalimab (JS001) a breakthrough therapy as a potential treatment of nasopharyngeal carcinoma (NPC), one of the most common cancers in China and one lacking treatment options elsewhere. This designation is given to medications for serious or life-threatening conditions that have the potential to provide significant advantages over current alternatives, and…
Patient dosing has begun in Zion Pharma‘s Phase 1 clinical trial in the United States to evaluate the safety of its investigational HER2 inhibitor, ZN-A-1041, in people with HER2-positive breast cancer and other solid tumors. “We are excited to have initiated our Phase 1 trial for ZN-A-1041,” Zack Cheng, PhD, chairman, CEO, and co-founder of…
The European Medicines Agency has agreed to review Bristol Myers Squibb’s application requesting approval for the dual immunotherapy regimen Opdivo (nivolumab) and Yervoy (ipilimumab) for untreated, inoperable malignant pleural mesothelioma (MPM). This decision comes after promising data from the Phase 3 CheckMate-743 trial (NCT02899299), in which the immunotherapy combo prolonged patients’ lives from a median of 14.1 months…
