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#Follicular Lymphoma

cancertherapyadvisor.com

Zydelig US Indications Withdrawn for Follicular Lymphoma, Small Lymphocytic Leukemia

Gilead Sciences has voluntarily withdrawn the US indications for Zydelig® (idelalisib) for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). In 2014, Zydelig received accelerated approval for these indications based on data from a phase 2 study (ClinicalTrials.gov Identifier: NCT01282424), which showed...
HEALTH
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CASI announces FDA’s Orphan Drug Designation for follicular lymphoma candidate

CASI Pharmaceuticals (NASDAQ:CASI) announced that the FDA had awarded its partner BioInvent International, the Orphan Drug Designation (ODD) for an investigational therapy targeted at follicular lymphoma, the most prevalent form of slow-growing Non-Hodgkin’s lymphoma. BI-1206, BioInvent's lead asset, is currently undergoing two Phase 1/2 trials: one in combination with...
MEDICAL & BIOTECH
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Monthly Prescribing Reference

Zydelig US Indications Withdrawn for Follicular Lymphoma, Small Lymphocytic Leukemia

Gilead Sciences has voluntarily withdrawn the US indications for Zydelig® (idelalisib) for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). In 2014, Zydelig received accelerated approval for these indications based on data from a phase 2 study (ClinicalTrials.gov Identifier: NCT01282424), which showed...
INDUSTRY
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TRENDING TOPICS
cancernetwork.com

FDA Notified About Withdrawal of Idelisib U.S. Indication for Follicular Lymphoma and Small Lymphocytic Leukemia

Gilead Sciences has announced the voluntary withdrawal of idelisib from the United States market in several indications including follicular lymphoma and small lymphocytic leukemia. Idelisib has been voluntarily withdrawn from several indications in the United States, including follicular lymphoma and small lymphocytic leukemia (SLL), according to a press release from...
MEDICAL & BIOTECH
targetedonc.com

Idelalisib for Relapsed FL and SLL Voluntarily Withdrawn from US Market

Without confirmed clinical benefit in follicular lymphoma and small lymphocytic leukemia, idelalisib's indications for these malignancies were withdrawn from the United States market. The developer of idelalisib (Zydelig), Gilead, has announced the withdrawal of 2 indications for the agent from the United States (US), according to a press release. Idealisib...
MedPage Today

How Parsaclisib Compares to Other PI3K Inhibitors for Follicular Lymphoma

In the phase II CITADEL-203 trial presented at the American Society of Hematology (ASH) annual meeting, patients with relapsed/refractory follicular lymphoma who were treated with parsaclisib -- an investigational, potent, highly selective, next-generation PI3Kδ inhibitor -- demonstrated rapid and durable clinical responses. MedPage Today brought together three expert leaders...
Nature.com

Mutated RAS-associating proteins and ERK activation in relapse/refractory diffuse large B cell lymphoma

Diffuse large B cell lymphoma (DLBCL) is successfully treated with combination immuno-chemotherapy, but relapse with resistant disease occurs in"‰~"‰40% of patients. However, little is known regarding relapsed/refractory DLBCL (rrDLBCL) genetics and alternative therapies. Based on findings from other tumors, we hypothesized that RAS-MEK-ERK signaling would be upregulated in resistant tumors, potentially correlating with mutations in RAS, RAF, or associated proteins. We analyzed mutations and phospho-ERK levels in tumor samples from rrDLBCL patients. Unlike other tumor types, rrDLBCL is not mutated in any Ras or Raf family members, despite having increased expression of p-ERK. In paired biopsies comparing diagnostic and relapsed specimens, 33% of tumors gained p-ERK expression, suggesting a role in promoting survival. We did find mutations in several Ras-associating proteins, including GEFs, GAPs, and downstream effectors that could account for increased ERK activation. We further investigated mutations in one such protein, RASGRP4. In silico modeling indicated an increased interaction between H-Ras and mutant RASGRP4. In cell lines, mutant RASGRP4 increased basal p-ERK expression and lead to a growth advantage in colony forming assays when challenged with doxorubicin. Relapsed/refractory DLBCL is often associated with increased survival signals downstream of ERK, potentially corresponding with mutations in protein controlling RAS/MEK/ERK signaling.
CANCER
philanthropynewsdigest.org

Follicular Lymphoma Foundation invites applications for research

Established in 2019 as an international effort to identify new treatments and cures for follicular lymphoma, the Follicular Lymphoma Foundation (FLF) invites applications for the FLF CURE FL (Curative Research to Eliminate Follicular Lymphoma) Awards of up to $500,000 in support of two-year research projects designed to accelerate the development of therapeutic candidates that have the potential to cure FL at first relapse, either as monotherapy or in a combination approach. FLF intends to award up to four research grants.
CANCER
memphissun.com

BioInvent: The FDA Grants Orphan Drug Designation to BI-1206 for the Treatment of Follicular Lymphoma

LUND, SWEDEN / ACCESSWIRE / January 19, 2022 / BioInvent International (STO:BINV) Clinical data clearly suggest BI-1206 may restore the response to rituximab. BioInvent International AB ('BioInvent') (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces that its anti-FcyRllB antibody BI-1206 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma.
onclive.com

Gilead Sciences Withdraws Idelalisib Relapsed Follicular Lymphoma, SLL Indications in the United States

Gilead Sciences, Inc. has decided to voluntarily withdraw the indications of idelalisib in patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma who had received at least 2 prior systemic therapies. Gilead Sciences, Inc. has decided to voluntarily withdraw the indications of idelalisib (Zydelig) in patients with...
onclive.com

Intensive Chemotherapy Falls a Few Steps Behind in Leukemia and Lymphoma

Naval Daver, MD, discusses the latest developments in acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, and follicular lymphoma. The management of acute and chronic leukemias and lymphoma is becoming less reliant on intensive chemotherapy, explained Naval Daver, MD, who added that this paradigm shift has reflected a greater dependence instead on antibody-drug conjugates, BTK inhibitors, and FLT3/IDH inhibitors.
CANCER
wsau.com

Gilead withdraws use of Zydelig to treat two types of cancer

(Reuters) – Gilead Sciences Inc has notified the U.S. health regulator of its decision to voluntarily withdraw the use of its drug Zydelig for two types of cancer – follicular lymphoma and small lymphocytic leukemia. (Reporting by Leroy Leo in Bengaluru; Editing by Arun Koyyur)
pharmacytimes.com

FDA Grants Regenerative Medicine Advanced Therapy, Fast Track Designations to Novel CAR T-Cell Therapy for Relapsed, Refractory B-cell Non-Hodgkin Lymphoma

C-CAR039 showed positive efficacy and safety data in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Officials with the FDA have granted both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation to C-CAR039, a novel autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL).
cancertherapyadvisor.com

Tisagenlecleucel Deemed Effective in Relapsed/Refractory Follicular Lymphoma

Tisagenlecleucel was deemed safe and effective for patients with relapsed/refractory follicular lymphoma (FL) based on the primary analysis of the ELARA trial, which was published in Nature Medicine. The phase 2 trial (ClinicalTrials.gov Identifier: NCT03568461) was designed to evaluate the safety and efficacy of the chimeric antigen receptor (CAR) T-cell...
CANCER
targetedonc.com

FDA Grants Fast Track Designation to C-CAR039 for DLBCL

The FDA granted both a regenerative medicine advanced therapy and fast track designation to C-CAR039 for relapsed or refractory diffuse large B-cell lymphoma. The FDA has granted both a fast-track designation and regenerative medicine advanced therapy designation to the autologous bi-specific CAR-T therapy that targets both CD19 and CD20, C-CAR039, for the treatment of relapsed or refractory diffuse large B cell lymphoma (DLBCL), according to a press release by Cellular Biomedicine Group Inc.1.
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