Tag Archives: small lymphocytic lymphoma

December, 2018

5 December
Imbruvica Combination Regimen Significantly Improved Survival in Phase 3 Trial in Previously Untreated and Younger CLL Patients

NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today shared results from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), National Cancer Institute (NCI)-sponsored, Phase 3 study (E1912) evaluating IMBRUVICA® (ibrutinib) plus rituximab versus the current National Comprehensive Cancer Network (NCCN) guidelines Category 1 treatment of fludarabine, cyclophosphamide …
Share

17 October
FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Combination with Gazyva for Previously Untreated Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or …
Share

11 June
FDA Approves Venclexta Plus Rituxan for People with Previously Treated Chronic Lymphocytic Leukemia

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan®(rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or …
Share

24 May
Imbruvica Plus Gazyva Improves Progression-Free Survival in Phase 3 Study in CLL/SLL Patients

NORTH CHICAGO, Ill., May 24, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Phase 3 iLLUMINATE (PCYC-1130) trial met its primary endpoint of improvement in progression-free survival (PFS). The study evaluated IMBRUVICA® (ibrutinib) in combination with GAZYVA® (obinutuzumab) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) …
Share

9 April
FDA Accepts NDA and Grants Priority Review to Verastem’s Duvelisib

BOSTON–(BUSINESS WIRE)–Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product …
Share

6 September
Verastem’s Duvelisib Succeeds in Late-Stage Blood Cancer Study

BOSTON–(BUSINESS WIRE)–Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today reported positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first in class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta …
Share

25 February
AstraZeneca and Acerta Pharma’s Acalabrutinib Recommended for EU Orphan Status for 3 Indications

AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the …
Share