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Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients. The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a […]

Innovent Biologics begins parsaclisib phase 2 trial in follicular lymphoma

Innovent Biologics has dosed the first patient in a phase 2 trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor in follicular lymphoma (FL). The goal of the study being held in China is to assess the efficacy and safety of parsaclisib in patients having recurrent or refractory follicular lymphoma or marginal zone lymphoma […]

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Epizyme gets FDA priority review for TAZVERIK in follicular lymphoma

Epizyme has been granted priority review by the US Food and Drug Administration (FDA) for the use of TAZVERIK (tazemetostat) in relapsed or refractory follicular lymphoma (FL). As per the new drug application (NDA) that has been accepted by the FDA, the Massachusetts-based biopharma company is seeking the accelerated approval of the methyltransferase inhibitor for […]

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Soligenix all set to begin FLASH clinical trial for SGX301 in CTCL

US biopharma company Soligenix has wrapped up enrolling patients for its phase 3 Fluorescent Light Activated Synthetic Hypericin clinical trial (FLASH clinical trial) for SGX301 (synthetic hypericin) in cutaneous T-cell lymphoma (CTCL). The late-stage study enrolled 169 subjects in the FLASH clinical trial. This was after Soligenix secured positive interim analysis, which included a prospectively […]

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Verastem gets FDA orphan drug status for COPIKTRA for T-Cell lymphoma

Verastem Oncology has secured orphan drug designation for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), from the US Food and Drug Administration (FDA) for the treatment of T-Cell lymphoma. COPIKTRA has FDA approval for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following more than two prior therapies. The PI3K also has […]

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Pixuvri EMA approval : Servier NHL drug secures standard marketing authorization in Europe

Pixuvri EMA approval : French pharma company Servier has secured full approval for Pixuvri (pixantrone) from the European Commission (EC) as monotherapy for aggressive non-Hodgkin B-cell lymphoma (NHL) in adult patients whose condition is multiply relapsed or refractory. Pixuvri EMA approval Since 2012, Pixantrone has been available in Europe to patients following conditional approval, which […]

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Takeda bags ADCETRIS EC approval for CD30+ Stage IV Hodgkin lymphoma

ADCETRIS EC approval : The European Commission (EC) has expanded the approval of Takeda Pharmaceutical’s ADCETRIS (brentuximab vedotin) to cover treatment of previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adult patients. ADCETRIS is an antibody-drug conjugate (ADC) that targets CD30, which is a defining marker of […]

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Kite Car T therapy Yescarta bags FDA approval for type of lymphatic cancer

Yescarta FDA approval : Kite Pharma has bagged the US FDA approval for its chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) for a type of lymphatic cancer (Lymphoma). FDA Approves New Lymphoma Drug Yescarta The Car T therapy from the Gilead subsidiary will be available as a new treatment option in […]

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