FDA approves Jevtana
SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for advanced prostate cancer, the agency said Thursday.
The FDA announced the approval of Sanofi-Aventis’ Jevtana (cabazitaxel), a chemotherapy drug used with the steroid prednisone. The agency said the drug was the first treatment for advanced, hormone-refractory prostate cancer that has worsened during or after treatment with docetaxel, also a chemotherapy drug used in advanced prostate cancer. Hormone refractory prostate cancer happens when prostate tumors continue to grow despite treatments meant to reduce the body’s production of the male hormone testosterone, which helps prostate tumors grow.
“Patients have few therapeutic options in this disease setting,” FDA Center for Drug Evaluation and Research Office of Oncology Products director Richard Pazdur said. “FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”
Stater Bros. continues fundraising efforts for blood cancers
SAN BERNARDINO, Calif. Stater Bros. is partnering with The Leukemia & Lymphoma Society for three weeks in June to raise funds for leukemia, lymphoma and Hodgkin’s disease, the California-based grocer said Wednesday.
All 167 Stater Bros. locations will be participating in the fundraising campaign, which will offer customers the opportunity to purchase $1 paper balloons. The proceeds will benefit The Leukemia & Lymphoma Society. Last year, Stater Bros. raised more than $300,000 for the organization — 2010 marks the third year for the partnership.
“The Stater Bros. supermarket family is very happy to be able to give back because there are so many people who have been affected by blood cancers and it is imperative that we join in the fight to find a cure,” stated Jack Brown, chairman and CEO of Stater Bros. “We do not just do business in a community, we are part of each and every community we serve.”
Abbott, Neurocrine Biosciences to commercialize elagolix
ABBOTT PARK, Ill. Two drug makers will work together to develop a drug for the treatment of endometriosis, a condition estimated to affect 100 million women around the world.
Abbott and Neurocrine Biosciences said they would develop and commercialize the drug elagolix, which recently finished a mid-stage study as a treatment for endometriosis and also is under development as a treatment for uterine fibroids. Endometriosis causes chronic pelvic pain throughout the menstrual cycle and dysmenorrhea, pain associated with mestruation. Uterine fibroids are benign tumors that form on the wall of the uterus.
“Extensive preclinical and clinical experience with elagolix suggests this drug could be an important advance for women with endometriosis and uterine fibroids, highly prevalent conditions where there is a need for new treatments,” Abbott SVP pharmaceutical research and development John Leonard stated. “This agreement enhances Abbott’s late-stage pipeline, with the potential for additional compounds in earlier-stage development.”
Abbott will pay $75 million upfront to Neurocrine while funding ongoing development activities. Neurocrine also will be eligible to receive milestone payments of around $500 million and potential royalties.