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.
FDA has approved Koselugo (selumetinib) for the treatment of pediatric patients, two years and older, with neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves.
FDA has approved mitomycin (Jelmyto) for adult patients with low-grade upper tract urothelial cancer.
Merck April 15 introduced Ontruzant(trastuzumab-dttb), a biosimilar of the reference biologic medicine Herceptin, to the U.S. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials.
FDA has approved Braftovi (encorafenib) in combination with Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.
FDA has approved luspatercept-aamt (Reblozyl, sponsored by Celgene Corp) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.
Myriad Genetics has received reimbursement and launched the BRACAnalysis Diagnostic System in Japan to help physicians determine which people affected with breast and ovarian cancer have hereditary breast and ovarian cancer syndrome and qualify for additional diagnostic and medical management.
