Agenus is seeking U.S. approval of balstilimab, its investigational immunotherapy for the treatment of recurrent or metastatic cervical cancer, which has limited effective treatment options and disproportionately affects younger people. The company has begun a rolling submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA). This means it will…
The MammaCare Foundation is offering a simulator to help train healthcare professionals and students in performing manual breast exams, with the aim of improving an early diagnosis of breast cancer. Diagnosing breast cancer early on can allow treatment to be started before the tumor grows or spreads elsewhere. As such, an early diagnosis breast cancers is a…
Stand Up To Cancer (SU2C) has awarded the 2020 SU2C Sharp Tank Award to Catherine Marinac, PhD, to support her research examining how interventions in patients with precursor multiple myeloma can be tailored to certain populations, especially those that are underserved. Marinac, a Dana-Farber Cancer Institute scientist, earned the $100,000 award as part of a…
The U.S. Food and Drug Administration (FDA) has approved a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line therapy for adults with inoperable malignant pleural mesothelioma (MPM), a rare but aggressive cancer that affects the lungs’ protective tissue lining. The FDA’s decision was announced less than six weeks after Bristol Myers Squibb, the therapies’ developer, submitted an…
Veru has completed enrollment for the second portion of a Phase 1/2 study of VERU-111, its investigational therapy for men with metastatic castration-resistant prostate cancer (mCRPC) who failed to respond to treatment with a new androgen receptor inhibitor. The open-label Phase 1/2 trial (NCT03752099) will evaluate the compound’s safety and efficacy in 40 men with…
A lab-grown, three-dimensional (3D) ovarian tumor model will give researchers a new way to study tumor growth in ovarian cancer and to test how tumors might respond to treatments, scientists say. The proof-of-concept study, “Peptide-protein coassembling matrices as a biomimetic 3D model of ovarian cancer,” was published in the journal Science Advances. Preclinical studies of…
The U.S. Food and Drug Administration has granted fast track status to immuno-oncology candidate eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy as a first-line treatment for patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC). Fast track designation speeds clinical development, regulatory review, and marketing approval of potential medications for serious…
Oncopeptides has formally opened sEAPort, its open-label expanded access program allowing adults with triple-refractory multiple myeloma to access the investigational medicine melflufen (melphalan flufenamide) before its approval. sEAPort (NCT04534322) is available to patients in the U.S. who tried at least two prior lines of therapy and failed to respond to at least one proteasome inhibitor, one immunomodulatory…
Eureka Therapeutics has started enrolling adults with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, in a Phase 1/2 trial of its investigational ET140203 T-cell therapy. The trial, called ARYA-1 (NCT04502082), seeks to enroll around 50 patients whose tumors contain alpha-fetoprotein (AFP), a protein that is overly produced by some types of…
Lantheus Holdings has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of PyL, an investigational imaging agent used to locate prostate cancer lesions. The new drug application (NDA) sent to the FDA includes a request for priority review, which if granted may shorten PyL’s regulatory review process from the usual…
