Clovis Oncology Inc. said the European Union's European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending an additional indication to include rucaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
FDA has granted orphan drug designation to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer. The designation follows the recent presentation of the first clinical data for M7824 in BTC at the European Society of Medical Oncology congress in October.
FDA has approved Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
FDA has published a draft guidance on “class labeling” of diagnostic tests for oncology therapeutic products, where scientifically appropriate.
FDA has published a document outlining it approach to interpretation of real-world evidence.
FDA has granted an accelerated approval to Venclexta (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine, for the treatment of people with newly-diagnosed acute myeloid leukemia, who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.
FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia in adults who are 75 years of age or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy.
FDA has approved Xospata (gilteritinib) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test.
FDA has approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma to be used as a single agent or in combination with chemotherapy.
Ziopharm Oncology Inc., announced a clinical supply agreement with Regeneron Pharmaceuticals Inc. to evaluate Ziopharm's Ad-RTS-hIL-12 plus veledimex in combination with Regeneron's PD-1 antibody Libtayo (cemiplimab-rwlc) to treat patients with recurrent glioblastoma.
