FDA

January 11, 2019

Epizyme Planning to Request FDA’s Accelerated Approval of Tazemetostat for Follicular Lymphoma Patients

News

Epizyme plans to ask the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat as a treatment for people with relapsed or refractory follicular lymphoma with or without EZH2 activating mutations. ... Read more

October 8, 2018

Portola’s Cerdulatinib Wins Orphan Drug Designation for Peripheral T-cell Lymphoma

News

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Portola Pharmaceuticals‘ investigative therapy cerdulatinib to treat patients with peripheral T-cell lymphoma (PTCL), the company announced. Orphan drug designation aims to encourage therapies for ... Read more

October 1, 2018October 3, 2018

FDA Approves Copiktra Capsules for 2 Lymphoma Types, Verastem Announces

News

The U.S. Food and Drug Administration approved Copiktra (duvelisib) capsules for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a minimum of two prior therapies. ... Read more

August 28, 2018August 28, 2018

FDA Approves Imbruvica-Rituxan Combo Therapy for Rare Type of Lymphoma

News

The U.S. Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib) plus Rituxan (rituximab) for the treatment of patients with a rare type of non-Hodgkin’s lymphoma called Waldenström’s macroglobulinemia (WM). This represents the first and only chemotherapy-free combination ... Read more

August 22, 2018

FDA Grants CPI-613 Orphan Drug Status For Peripheral T-Cell Lymphoma Treatment

News

Therapeutic candidate CPI-613, developed by Rafael Pharmaceuticals, received orphan drug designation by the U.S. Food and Drug Administration for the treatment of peripheral T-cell lymphoma (PTCL). This is the fifth ... Read more

July 17, 2018

FDA OKs Adagene’s ADG-106 for Clinical Trial in Solid Tumors, Non-Hodgkin’s Lymphoma

News

Adagene soon will initiate a Phase 1 clinical trial testing its lead product, ADG-106, in patients who have advanced solid tumors and non-Hodgkin’s lymphoma, the company announced. This follows the U.S. ... Read more

May 31, 2018

Xalkori Named Breakthrough Therapy for Difficult-to-Treat Rare Lymphoma

News

The U.S. Food and Drug Administration granted breakthrough therapy designation to Pfizer’s Xalkori (crizotinib) for the treatment of a subgroup of difficult-to-treat systemic anaplastic large cell lymphoma (ALCL). The FDA’s ... Read more

May 8, 2018

Forty Seven’s 5F9 Immunotherapy on FDA Fast Track for DLBCL, Follicular Lymphoma

News

The U.S. Food and Drug Administration has granted fast track status to Forty Seven’s lead candidate Hu5F9-G4 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. ... Read more

May 3, 2018

FDA Approves Kymriah for Relapsed or Refractory Large B-cell Lymphoma

News

The U.S. Food and Drug Administration (FDA) has approved Kymriah (tisagenlecleucel) for the treatment of adults with relapsed or refractory large B-cell lymphoma, Novartis announced. Specifically, the approval of intravenous Kymriah suspension is ... Read more

April 27, 2018April 27, 2018

FDA Orders Enrollment Hold on Tazemetostat Clinical Trials

News

Patient enrollment for clinical trials of Epizyme’s tazemetostat is temporarily on hold. The decision from the U.S. Food and Drug Administration (FDA) follows a safety report of a pediatric patient ... Read more