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.
FDA has approved Herzuma (trastuzumab-pkrb) for injection in the same indications as the biosimilar Herceptin.
Ideaya Biosciences Inc. and Pfizer Inc. have formed a clinical trial collaboration and supply agreement.
FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma
FDA granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo and Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
FDA has accepted Mylan's Biologics License Application or MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.
