ITUS Corp. said it has entered into a Cooperative Research and Development Agreement with Moffitt Cancer Center, to advance toward human clinical testing, a Chimeric Antigen Receptor T-Cell technology aimed initially at ovarian cancer, and eventually additional solid tumors.
FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.
FDA granted a regular approval to obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma.
FDA has granted regular approval to dasatinib (Sprycel) for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.
FDA approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
FDA authorized Memorial Sloan Kettering Cancer Center's Integrated Mutation Profiling of Actionable Cancer Targets tumor profiling test, an in vitro diagnostic test that can identify a higher number of genetic mutations that may be found in various cancers than any test previously reviewed by the agency.
HALOZYME THERAPEUTICS INC. said FDA has accepted Genentech’s Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE platform), approved and marketed under the MabThera SC brand in countries outside the U.S. Halozyme Therapeutics is a biotechnology company focused... […]
FDA has granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, as detected by an FDA-approved test.
FDA has expanded the approval of Zelboraf (vemurafenib), a kinase inhibitor, to include the treatment of certain adult patients with Erdheim-Chester Disease, a rare blood cancer. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD.
FDA has granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.
