FDA has approved the BRACAnalysis CDx test for use as a companion diagnostic to identify men with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza (olaparib).
Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application to FDA, seeking approval for Xpovio (selinexor), its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with previously treated multiple myeloma.
FDA has approved Retevmo (selpercatinib) capsules to treat non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers in patients whose tumors have an alteration in a specific gene (RET).
FDA has expanded the indication of Lynparza (olaparib) to include its combination with bevacizumab for first-line maintenance treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
FDA has granted accelerated approval to Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping as detected by an FDA-approved test.
FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.
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.
