Lisa Schwartz, professor of Medicine and of Community and Family Medicine at Dartmouth Medical School died on November 29 after a seven-year struggle with cancer—a terrible loss to all who knew her.
On the eve of the Thanksgiving holiday, FDA delivered a flurry of decisions: approvals for two therapies—venetoclax and glasdegib—to treat a deadly form of blood cancer called acute myeloid leukemia (AML), and a priority review designation for another therapy—quizartinib—to treat the same disease. A fourth therapy to treat AML—gilteritinib—received an FDA approval on Nov. 28.
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.
Researchers with Biodesix and Genentech presented findings on a test designed to predict response to atezolizumab (Tecentriq) in patients with non-small cell lung cancer.
Cardiovascular toxicities seen early in treatment with immune checkpoint inhibitors
