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.
Seattle Genetics Inc. said it has submitted a supplemental Biologics License Application to FDA based on data from the phase III ECHELON-1 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.
FDA has approved Yescarta (axicabtagene ciloleucel), a genetically modified cell therapy, to treat adult patients with certain types of large B cell lymphoma who have not responded to or have relapsed after at least two other kinds of treatment.
AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, said the FDA has granted accelerated approval to Calquence (acalabrutinib, previously known as ACP-196), a kinase inhibitor, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Scientists from within the industry, academia, and two U.S. national laboratories are working to streamline the process for development of cancer drugs. They are creating an open and sharable platform that integrates high-performance computing, shared biological data from public and industry sources, and emerging biotechnologies to dramatically accelerate the discovery.
Genentech announced FDA has accepted the company's supplemental Biologics License Application for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of advanced ovarian cancer.
