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FDA APPROVALS

  • 01 May 2020 2:35 PM | Anonymous

    The U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Read full press release.

  • 29 Apr 2020 9:48 AM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA, Merck) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen. Read full press release.

  • 23 Apr 2020 10:50 AM | Anonymous

    The U.S. Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA, Pharmacyclics LLC) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read full press release

  • 23 Apr 2020 10:48 AM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Read full press release.

  • 21 Apr 2020 9:12 AM | Anonymous

    The Food and Drug Administration approved (TUKYSA, Seattle Genetics, Inc.) in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Read full press release.

  • 21 Apr 2020 9:06 AM | Anonymous

    The Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Read full press release

  • 13 Apr 2020 8:31 AM | Anonymous

    The U.S. Food and Drug Administration approved selumetinib (Koselugo; AstraZeneca) for neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurocfibromas (PN). Read full press release.

  • 09 Apr 2020 1:52 PM | Anonymous

    The U.S. Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. Read full press release.

  • 09 Apr 2020 1:45 PM | Anonymous

    The U.S. Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic /myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Read full press release.

  • 01 Apr 2020 9:34 AM | Anonymous

    The U.S. Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Read full press release.

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