FDA has accepted a New Drug Application for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia who achieved complete remission, or CR with incomplete blood count recovery, following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation.
Caris Life Sciences has submitted two Pre-Market Approval applications for MI Exome CDx and MI Transcriptome CDx to FDA.
FDA has approved a supplemental New Drug Application for Zejula (niraparib) an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
FDA has granted an accelerated approval to a new dosing regimen of 400 mg every six weeks for Keytruda (pembrolizumab) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen.
FDA has granted Breakthrough Therapy Designation to mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
FDA has approved Tukysa in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can't be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.
FDA has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.
FDA has granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
FDA has approved Imbruvica (ibrutinib) in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA has approved PD-L1 IHC 22C3 pharmDx as a companion diagnostic to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with Keytruda on the Dako Omnis platform.
