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.
FDA March 27 approved Imfinzi (durvalumab) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer.
The European Medicines Agency's Committee for Medicinal Products for Human Use granted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with CHP (cyclophosphamide, doxorubicin, prednisone) as a treatment for adult patients with previously untreated systemic anaplastic large cell lymphoma.
The China National Medical Products Administration accepted a supplemental New Drug Application for Zejula (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
England's National Institute for Health and Care Excellence has rejected Keytruda (pembrolizumab) in patients who receive locally advanced or metastatic urothelial carcinoma who have had platinum-containing chemotherapy.
