Conditions

This post was originally published on this site The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy NKTR-214 with Opdivo (nivolumab) for untreated melanoma patients with either metastatic disease or who are unable to undergo surgery. A global Phase 3 clinical trial (NCT03635983) comparing the effectiveness and safety…

This post was originally published on this site The U.S. Food and Drug Administration (FDA) has accepted for review BeiGene‘s application requesting the approval of zanubrutinib for treating people with mantle cell lymphoma who received at least one prior therapy. BeiGene’s new drug application (NDA) received priority review status, which reduces review time from the…

This post was originally published on this site Kalytera’s cannabidiol (CBD) compound efficiently prevents graft-versus-host disease (GVHD) in patients receiving bone marrow transplants from matched unrelated donors, interim data from a Phase 2 study show. Considering the study’s positive results so far, the company announced that it will halt the Phase 2 study and proceed directly…

This post was originally published on this site When added to Avastin (bevacizumab), Lynparza (olaparib) reduces the risk of disease progression and death in women with advanced forms of ovarian cancer who are responding to their first-line treatment with platinum-based chemotherapy, a Phase 3 trial shows. Lynparza is an oral anti-cancer treatment jointly developed by AstraZeneca and Merck…

This post was originally published on this site The California Institute for Regenerative Medicine (CIRM) has granted a $9.28 million award to a group of City of Hope researchers carrying out a first-in-human Phase 1 clinical trial testing the safety and efficacy of CAR T-cell therapy for the treatment of women with HER2-positive breast cancer…

This post was originally published on this site People with hepatitis C who develop sarcoidosis may be safely treated with adalimumab, marketed by Abbvie as Humira, a case report suggests. The case was described in a study, “Sarcoidosis with concomitant hepatitis C infection treated successfully with adalimumab,” which was published in the Journal of the German Society…

This post was originally published on this site People in Japan newly diagnosed with multiple myeloma and ineligible for a stem cell transplant can now use a combination of Darzalex (daratumumab) and standard treatment, the companies behind the therapy announced. The approval, by the country’s Ministry of Health, Labor and Welfare, was based on data from the ALCYONE Phase…

This post was originally published on this site Rubraca (rucaparib), a therapy for relapsed or progressive ovarian, fallopian, or primary peritoneal cancer, was provisionally rejected for use on England’s National Health Service (NHS). In justifying its decision, the National Institute of Health and Care Excellence (NICE), the U.K. agency that provides healthcare guidance, cited a…

This post was originally published on this site The U.S. Food and Drug Administration (FDA) has agreed to review Astellas Pharma and Pfizer‘s application for Xtandi (enzalutamide), requesting its approved use be expanded to include men whose metastatic prostate cancer still responds to hormone therapy. The supplemental new drug application, covering men with metastatic hormone-sensitive prostate…

This post was originally published on this site I hate giving advice, but I’ve learned lessons through my breast cancer journey that may be helpful to others in similar situations. After my diagnosis, a doctor told me I had three months to live. Against the odds, I survived, and along the way, I experienced profound…

This post was originally published on this site A European Medicines Agency (EMA) committee has recommended orphan drug designation for Ziopharm Oncology‘s interleukin (IL)-12 gene therapy — known as the Controlled IL-12 platform — for the treatment of glioblastoma, a very aggressive type of brain cancer. The European Commission will now decide whether or not to grant…