Tag Archives: MCL

October, 2017

31 October
FDA Approves AstraZeneca’s Calquence for Treatment of Adults with Previously-Treated Mantle Cell Lymphoma

AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Calquence (acalabrutinib). Calquence is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 …
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30 March
Genmab Discontinues Mid-Stage Non-Hodgkin’s Lymphoma Study

Copenhagen, Denmark; March 30, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner for daratumumab, Janssen Biotech, Inc., has decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL). The study …
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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 …
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