Epizyme gets FDA priority review for TAZVERIK in follicular lymphoma

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 […]

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

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 […]

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

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 […]

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

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 […]

FDA grants approval to Yescarta for treatment of certain types of lymphoma

Kite Pharma has clinched the US FDA approval for its Car T therapy Yescarta (axicabtagene ciloleucel) for treating a type of lymphatic cancer in patients who have no more treatment options left and are staring at a dire prognosis.

FDA grants approval to Yescarta for treatment of certain types of lymphoma

In a significant development for lymphoma treatment, Kite Pharma, a subsidiary of Gilead Sciences, has received approval from the U.S. Food and Drug Administration (FDA) for its chimeric antigen receptor T cell (CAR T) therapy, Yescarta (axicabtagene ciloleucel). This new therapy is now approved for adult patients in the United States with relapsed or refractory […]