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FDA APPROVALS

  • 09 Apr 2020 1:45 PM | Deleted user

    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 | Deleted user

    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.

  • 11 Mar 2020 4:11 PM | Deleted user

    The U.S. Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read full press release

  • 03 Mar 2020 9:27 AM | Deleted user

    The U.S. Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Read full press release.

  • 27 Feb 2020 9:19 AM | Deleted user

    The U.S. Food and Drug Administration granted accelerated approval to tazemetostat (Tazverik; Epizyme) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Read full press release.

  • 27 Feb 2020 7:13 AM | Deleted user

    The U.S. Food and Drug Administration approved neratinib (Nerlynx; Puma Biotechnology) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. Read full press release.

  • 08 Jan 2020 2:47 PM | Deleted user

    The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Read full press release.

  • 07 Jan 2020 1:24 PM | Deleted user

    The U.S. Food and Drug Administration approved olaparib (Lynparza; AstraZeneca) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Read full press release

  • 07 Jan 2020 1:19 PM | Deleted user

    The U.S. Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Read full press release

  • 19 Dec 2019 1:49 PM | Deleted user

    The U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev; Astellas) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Read full press release.

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Massachusetts Society of Clinical Oncologists

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Tel: 781.434.7329 | Fax: 781.464.4896 | email: msco@mms.org


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