FDA approved a new use for Lymphoseek Injection (technetium 99m tilmanocept), a radioactive diagnostic imaging agent, to determine the extent squamous cell carcinoma has spread in the body’s head and neck region.
In 2013, Lymphoseek was approved to help identify lymph nodes closest to a primary tumor in patients with breast cancer or melanoma. It can now be used to guide testing of lymph nodes closest to a primary tumor for cancer, in patients with cancer of the head and neck.
Lymphoseek’s safety and effectiveness were established in a clinical trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin. All patients were injected with Lymphoseek. Surgeons subsequently removed suspected lymph nodes—those identified by Lymphoseek and those based upon tumor location and surgical practice—for pathologic examination. Results showed that Lymphoseek–guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system.
Lymphoseek is marketed by Navidea Biopharmaceuticals Inc.
FDA approved Aloxi injection (palonosetron HCl) for the prevention of nausea and vomiting due to chemotherapy in children as young as one month to less than 17 years old, including highly emetogenic cancer chemotherapy.
This is the first approval of a product for acute chemotherapy-induced nausea and vomiting prevention in patients aged one month to six months.
The approval was based on a randomized, double-blind, non-inferiority pivotal trial comparing single-dose intravenous Aloxi 20 mcg/kg given 30 minutes prior to chemotherapy to a standard of care IV ondansetron regimen of 0.15 mg/kg given 30 minutes prior to chemotherapy followed by infusions four and eight hours after the first dose of ondansetron.
Within the first 24 hours after chemotherapy, complete response, defined as no vomiting, no retching and no antiemesis rescue medication, was achieved in 59.4 percent of patients who received Aloxi 20 mcg/kg versus 58.6 percent of those who received the ondansetron regimen, meet its primary endpoint.
Treatment-emergent adverse events were comparable across both arms, with the most frequently reported in the palonosetron group being headaches. While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent CINV, the safety profile was consistent with the established profile in adults. Aloxi is sponsored by Eisai Inc. and Helsinn Group.
FDA granted Orphan Drug Designation to mocetinostat, as a treatment for myelodysplastic syndrome, developed by Mirati Therapeutics Inc.
Mocetinostat is being evaluated in phase II clinical studies in combination with Vidaza as a treatment for intermediate and high-risk MDS, as well as a single agent treatment in patients with diffuse large B-cell lymphoma and bladder cancer targeting specific genetic mutations in histone acetylation that increase the likelihood of response in tumor cells.
The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations or rare disorders that affect fewer than 200,000 people in theU.S.
Mocetinostat is an oral, spectrum-selective HDAC inhibitor. Thirteen clinical trials have been completed, which enrolled over 400 patients with a variety of hematologic malignancies and solid tumors. Mirati also plans to initiate phase II studies of mocetinostat as a single agent in patients with mutations in histone acetyl transferases in bladder cancer and DLBCL.
FDA approved the Invenia ABUS breast imaging technology, which uses 3D ultrasound to image women with dense breast tissue in approximately 15 minutes with new features that conform to the patient’s body and provide enhanced images.
Its sponsor, GE Healthcare, says the system can help clinicians find 35.7 percent more cancers in women with dense breasts than mammograms alone.
The Invenia ABUS uses the Reverse Curve transducer to conform to a woman’s anatomy, for better comfort and image performance. Further, the system uses Compression Assist, a feature which applies light levels of compression automatically to the breast for increased ease and image reproducibility.
The system will first be launched in Fairfax, Va., and Westchester County, N.Y., before being available nationwide later this year, according to GE Healthcare.
