Genentech, a member of the Roche Group, said FDA has accepted the company's supplemental Biologics License Application and granted priority review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma.
FDA approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.The agent is sponsored by Pfizer Inc.
Kymriah (tisagenlecleucel) became the first gene therapy available in the United States.
FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).
FDA granted regular approval to olaparib tablets (Lynparza) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. FDA granted this application Fast Track status.
Ocugen Inc. said FDA has granted orphan drug designation for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease.
On behalf of FDA, on Aug. 25 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live), a vaccine reserved for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.
FDA granted a regular approval to enasidenib (IDHIFA) for the treatment of adult patients with relapsed/refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test.
FDA approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia: newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
FDA gave nivolumab (Opdivo) an accelerated approval for the treatment of patients 12 years and older with mismatch repair deficient and microsatellite instability high metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.