The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
A comparison of three methods of predicting the risk of recurrence in women treated for estrogen-receptor–positive breast cancer found that only the breast cancer index (BCI)—a biomarker based on the expression levels of seven tumor-specific genes—accurately identified patients...
A family of microRNAs (miR-200) blocks cancer progression and metastasis by stifling a tumor’s ability to weave new blood vessels to support itself, researchers at The University of Texas MD Anderson Cancer Center reported in Nature Communications. Patients with lung, ovarian, kidney, or...
Syndax Pharmaceuticals Inc today announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor (ER)-positive breast cancer when added to exemestane in postmenopausal women whose...
Ceptaris Therapeutics, Inc, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug mechlorethamine gel (Valchlor) for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who...
A new study underway at Moffitt Cancer Center in Tampa, Florida, is investigating whether an intralesional injection of PV-10 (a substance derived from Rose Bengal, a staining agent that has been used to assess eye damage), is effective in reducing tumors and the spread of cancer in patients with...
In a phase III double-blind study (VENICE trial) reported in Lancet Oncology, Ian F. Tannock, DSc, of Princess Margaret Cancer Centre in Toronto, and colleagues evaluated the addition of the antiangiogenic agent aflibercept (Zaltrap) to standard docetaxel/prednisone therapy in patients with...
Previous studies have shown that anti-EGFR monoclonal antibody treatment can improve clinical outcomes in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. In the open-label phase III SPECTRUM trial, Jan B. Vermorken, MD, of Antwerp University Hospital and...
Pharmacyclics, Inc, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and...
In two large studies, the association between aspirin use and risk of colorectal cancer was affected by BRAF mutation status, with regular aspirin use associated with a lower risk of BRAF wild-type colorectal cancer but not with risk of BRAF-mutated cancer. The findings, published today in JAMA,...
Researchers have discovered and mapped the signaling network between two previously unconnected proteins, exposing a link that, if broken, could cut off cancer cell growth at its starting point. A team led by scientists at The University of Texas MD Anderson Cancer Center reported the tie between...
The U.S. Supreme Court ruled unanimously on Thursday that isolated human genes may not be patented. However, the creation of synthetic forms of DNA, known as complementary DNA (cDNA), is eligible for patent protection. The decision resolves the question brought before the Supreme Court justices in...
Low-dose weekly administration of paclitaxel resulted in equal progression-free survival but reduced overall toxicity compared to every-2-week dose-dense administration for women with higher-risk early-stage breast cancer who have undergone surgery, according to a phase III randomized trial....
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, trametinib (Mekinist) was...
A new clinical trial is testing whether targeting treatments to a genetic anomaly can lead to better treatments for castration-resistant metastatic prostate cancer. The trial, led by investigators at the University of Michigan Comprehensive Cancer Center, is being conducted at 11 sites throughout...
Hologic, Inc, announced today that the U.S. Food and Drug Administration (FDA) has approved the use of C-View, a new low-dose two-dimensional (2D) imaging software. C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of Hologic’s FDA-approved...
A phase I expansion study of the investigational drug MPDL3280A— an engineered PD-L1 targeted antibody—shows impressive tumor shrinkage rates in patients with several different cancers—including lung, melanoma, kidney, colorectal, and gastric cancers—that had progressed...
Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As...
Pharmacyclics, Inc, announced today that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm...
Researchers at the University of California, San Diego School of Medicine have shown that a new imaging dye, designed and developed at UC San Diego Moores Cancer Center, is an effective agent in detecting and mapping cancers that have reached the lymph nodes. The radioactive dye technetium Tc-99m...
The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Technetium Tc 99m tilmanocept is an...
A new immunoassay that tests for the presence of three biomarkers appears to be a valid screening method for the early detection of malignant kidney cancer, according to data published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research....
Launch of a website created to educate newly diagnosed patients, their families, and health-care providers about uveal melanoma, was announced recently by Castle Biosciences, Inc, a developer of prognostic tests for rare cancers. The website, MyUvealMelanoma.com, addresses the treatment of uveal...
In a major breakthrough for uterine serous carcinoma (USC), a chemoresistant, aggressive form of endometrial cancer, researchers at Yale Cancer Center have defined the genetic landscape of USC tumors, findings that point to new treatment opportunities. The collaborative team, which included...
Telik, Inc, announced that its product candidate, ezatiostat hydrochloride (Telintra), has been granted orphan drug designation by the FDA for the treatment of myelodysplastic syndrome (MDS). Ezatiostat is an investigational agent in development for the treatment of MDS and idiopathic chronic...
Dune Medical Devices, Inc, announced that the FDA has granted Premarket Approval to the MarginProbe System, the company’s breakthrough intraoperative tissue assessment tool for early-stage breast cancer surgery. The technology significantly improves surgeons’ ability to intraoperatively ...