Herzuma, a biosimilar to Genentech‘s Herceptin (trastuzumab), is now available in the U.S. for the same indications as the reference therapy, including for the treatment of HER2-positive breast cancers and stomach cancers. The treatment was approved by the U.S. Food and Drug Administration (FDA) in December 2018, the same year it was approved by the European Medicines Agency.…
Caregivers are the first line of defense between their loved ones and, well, everything. Like everyone on the planet, our brains are steeped with thoughts of the coronavirus. It’s our job to stand between our loved ones and the communicable disease, but it’s also our responsibility to keep them from becoming overwrought by all the…
Giving Dantrium (dantrolene) through the nose rather than by mouth may maximize its neuroprotective properties in treating conditions like Alzheimer’s disease, a new study suggests. The study, “Intranasal administration of dantrolene increased brain concentration and duration,” was published in the journal Plos One. Dantrium, produced by Par Sterile Products, is approved by the U.S. Food and Drug…
The Chinese regulatory agency has agreed to review Zai Lab‘s application asking that Zejula (niraparib) be approved as first-line maintenance therapy for women with ovarian cancer who are responding to platinum-based chemotherapy, the company announced. The supplemental New Drug Application (sNDA), submitted to the China National Medical Products Administration (NMPA), is for women with advanced epithelial…
A combination of Ninlaro (ixazomib), Revlimid (lenalidomide), and dexamethasone failed to significantly extend the time to disease progression or death in people with newly diagnosed multiple myeloma who are ineligible for stem cell transplants, compared with Revlimid and dexamethasone alone, results from a Phase 3 trial show. The combination did help patients live 13.5 months longer…
This post was originally published on this site The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Seattle Genetics’ tucatinib, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with locally advanced inoperable or metastatic HER2-positive breast cancer. The designation, which also includes those with brain metastases, is…
This post was originally published on this site “I wish we could put up some of the Christmas spirit in jars and open a jar of it every month.” —Harlan Miller For many people, Christmas is the most wonderful time of the year. The hustle and bustle of shopping for the perfect present, the ringing…
This post was originally published on this site Lynparza (olaparib), a breast and ovarian cancer treatment, is also showing promising results in men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in DNA repair genes, particularly the BRCA1 and BRCA2 genes, according to data from a Phase 2 study. The study’s final data, “Olaparib in patients…
This post was originally published on this site Aravive is recruiting participants for a Phase 1/2 clinical trial assessing a combination of its experimental treatment AVB-500 plus the immune checkpoint inhibitor Imfinzi (durvalumab) in women with platinum-resistant epithelial ovarian cancer. The trial (NCT04019288) is ongoing at the MD Anderson Cancer Center, in Texas, and is…
This post was originally published on this site For people with multiple myeloma who don’t respond well to an initial type of therapy, quickly switching to another type may improve clinical outcomes, a new study suggests. The study, “Response-adapted intensification with cyclophosphamide, bortezomib, and dexamethasone versus no intensification in patients with newly diagnosed multiple myeloma…
