Adding four months of androgen deprivation therapy (ADT) to radiation treatment extends survival and delays metastasis in men with unfavorable intermediate-risk prostate cancer, according to a secondary analysis of a Phase 3 clinical trial. However, that new trial analysis showed there were no such benefits to ADT therapy for men with favorable intermediate-risk prostate cancer undergoing…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to PC14586 as a potential treatment of advanced cancers that harbor a specific mutation affecting the protein p53, which includes some ovarian cancers. Fast track is given to support therapies with the potential to fill a serious unmet medical need. They are eligible…
Delays in breast cancer surgery due to the COVID-19 pandemic could cost 2,797 additional deaths in the U.S. over the next decade, according to a Kantar Health analysis. Such treatment delays also place patients at a higher risk of metastasis, or cancer spread, potentially increasing healthcare costs in the U.S. by an estimated $376 million…
After first rejecting a Sarclisa (isatuximab) triple combination therapy due to cost-effectiveness concerns, the U.K.’s National Institute for Health and Care Excellence (NICE) has given conditional approval to the treatment for relapsed or refractory multiple myeloma. The triple therapy includes Sarclisa in combination with Imnovid (pomalidomide, also sold as Pomalyst) and dexamethasone, a corticosteroid. It is particularly recommended for…
A committee of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of people with advanced, inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who previously received a chemo regimen containing fluoropyrimidine and a platinum agent. The European Commission will review this opinion from the Committee for Medicinal Products for Human…
Provenge (sipuleucel-T), by Dendreon Pharmaceuticals, is superior to Zytiga (abiraterone acetate) or Xtandi (enzalutamide) at prolonging the lives of men with metastatic castration-resistant prostate cancer (mCRPC) when added at any point in a treatment regimen, according to a real-life study in the U.S. The study, “A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in…
Shattuck Labs has opened a Phase 1 clinical trial to investigate its lead candidate, SL-172154, in treating people with advanced ovarian cancer, the company announced in a press release. The trial (NCT04406623) is recruiting up to 33 patients at three sites in the U.S.: the John Wayne Cancer Institute at Providence St. John’s Health Center in California,…
A committee of the European Medicines Agency (EMA) has recommended the conditional approval of Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). The recommendation by the Committee for Medicinal Products for Human Use (CHMP) for Kite Pharma‘s CAR T-cell therapy is specific for patients who received at least two…
NexImmune has dosed the first patient participating in its Phase 1/2 trial of NEXI-002, the company’s investigational T-cell therapy for multiple myeloma. The trial (NCT04505813), which is recruiting participants at several sites across the U.S., aims to enroll 22 to 28 patients with relapsed or refractory multiple myeloma, who failed to respond to at least…
Signatera, Natera’s personalized test to detect residual signs of cancer in people with solid tumors, will be used in an upcoming Phase 2 trial as a tool to identify patients with early HR-positive (hormone receptor-positive), HER2-negative (human epidermal growth factor 2-negative) breast cancer who are at high risk of cancer relapse. The test also will be…
