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.
The clinical collaboration between Immunomedics Inc. and AstraZeneca and MedImmune for the development of Imfinzi (durvalumab) and sacituzumab govitecan combination therapy has been broadened to include second-line metastatic non-small cell lung cancer, the companies said.
FDA has granted priority review for Genentech's supplemental Biologics License Application for Tecentriq (atezolizumab) plus chemotherapy, Abraxane (albumin-bound paclitaxel; nab-paclitaxel) for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent, superior and sustained efficacy compared to endocrine therapy alone.
FDA approved Erleada (apalutamide) for the treatment of non-metastatic castration-resistant prostate cancer. This is the first FDA-approved treatment for this indication.
FDA has expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma.
