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…
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…
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kleo Pharmaceuticals‘ KP1237, an investigational treatment for multiple myeloma. The designation grants various development incentives to medications that address rare disorders affecting fewer than 200,000 people annually in the U.S. Incentives include regulatory support and financial benefits that will help accelerate the…
A five-year grant of more than $2 million from the National Cancer Institute (NCI) will support research investigating the link between prostate cancer cells and the fatty cells — adipocytes — found in bone marrow. Izabela Podgorski, PhD, associate professor of pharmacology at Wayne State University School of Medicine in Michigan, will lead the project being funded by the the…
Compass Therapeutics‘ CTX-2026, an antibody targeting the protein BTN3A1, could be therapeutic in ovarian cancer by helping the immune system destroy cancer cells, preclinical data show. The study, “BTN3A1 governs antitumor responses by coordinating αβ and γδ T cells,” was published in the journal Science. The body’s immune system is responsible for fighting off infections…
TTC-352, an investigational oral treatment for patients with metastatic ER-positive breast cancer that no longer responds to hormone therapy, was found to be safe and tolerable at high dose in a Phase 1 clinical study. The treatment also showed a potential for effectiveness, with half of those who finished the trial achieving stable disease for…
