FDA Panel Recommends Approval of Roferon-A for Treatment of CML

News
Article
Oncology NEWS InternationalOncology NEWS International Vol 4 No 6
Volume 4
Issue 6

WASHINGTON--The FDA's Biological Response Modifiers Advisory Committee unanimously recommended approval of Hoffmann-La Roche Inc.'s Roferon-A (interferon alfa-2a, recombinant) for the treatment of adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (CML). The interferon is currently approved for use in hairy cell leukemia and AIDS related Kaposi's sarcoma.

WASHINGTON--The FDA's Biological Response Modifiers Advisory Committeeunanimously recommended approval of Hoffmann-La Roche Inc.'s Roferon-A(interferon alfa-2a, recombinant) for the treatment of adult patientswith Philadelphia chromosome positive chronic myelogenous leukemia(CML). The interferon is currently approved for use in hairy cellleukemia and AIDS related Kaposi's sarcoma.

A large randomized study suggests that Roferon-A slows progression,elicits more cytogenetic responses, and improves survival in thesepatients. It is currently designated as an orphan drug for CML,since only 2,500 patients a year are affected with the disease.

Articles in this issue
IDEC-C2B8 Antibody Is in Phase III Testing for B-Cell Lymphoma
Dr. Peters Named Head of the Michigan Cancer Foundation
Broad-Spectrum Sunscreens Block UVA and UVB
Trials of AccuSite Injectable Gel From Matrix Begin in Basal Cell Ca
Outpatient ABMT at Duke Leads to Savings
Russia Is Taking First Steps to Deliver Its Health-Care System Out of Chaos
Algorithm Optimizes Value of CA125 II Screening for Ovarian Ca
Better Ovarian Cancer Outcome With IP Cisplatin
Counseling Must Go Hand in Hand With Genetic Testing for Breast Cancer
Epirubicin Effective But Toxicity Is Increased
Aggressive 16-Week Multidrug Regimen Improves Breast Cancer Survival
Telomerase Appears to Play a Role in Cancer Cell Immortality
Changes in Health-Care Delivery Could Alter System of Medical Ethics
Researchers Seek Pleural Effusions And Tissue to Create MCB Cell Lines
NIH Granted Gene Therapy Patent

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Subscribe Now!
Recent Videos
Despite CD19 CAR T-cell therapy exhibiting efficacy in patients with relapsed/refractory large B-cell lymphoma, less than half achieve long-term remission.
Current findings from the phase 1/2 CaDAnCe-101 trial show no predictive factors of improved responses with BGB-16673 in patients with CLL or SLL.
More follow-up data will better elucidate the impact of frontline use of hypomethylating agents in patients with myelodysplastic syndromes.
CancerNetwork® spoke with Neha Mehta-Shah, MD, MSCI, about the clinical landscape for patients undergoing treatment for rare lymphomas.
CAR T-cell therapy initially developed for mantle cell lymphoma was subsequently assessed in marginal zone lymphoma.
The efficacy of the BOVen regimen in chronic lymphocytic leukemia facilitated its evaluation in patients with mantle cell lymphoma.
Related Content
Unpacking the EPCORE NHL-1 Trial and Epcoritamab’s Promise in R/R LBCL

Unpacking the EPCORE NHL-1 Trial and Epcoritamab’s Promise in R/R LBCL

Ariana Pelosci
July 3rd 2025
Article

The EPCORE NHL-1 trial showed a 41% complete response rate with epcoritamab for patients with relapsed/refractory LBCL.

An expert panel highlights key presentations in multiple myeloma, lymphoma, and other hematologic malignancies at the 2025 ASCO Annual Meeting.

CAR T and Transplantation Advances Across Hematologic Cancers at ASCO 2025

Rahul Banerjee, MD, FACP;Taha Al-Juhaishi, MD;Muhammad Salman Faisal, MD
June 9th 2025
Podcast

An expert panel highlights key presentations in multiple myeloma, lymphoma, and other hematologic malignancies at the 2025 ASCO Annual Meeting.

Data support incorporating volumetric PET biomarkers into toxicity risk prediction for patients receiving CAR T-cell therapy for LBCL.

High Tumor Volume Confers CAR T-Cell Therapy Toxicity Risk in LBCL

Russ Conroy
June 30th 2025
Article

Data support incorporating volumetric PET biomarkers into toxicity risk prediction for patients receiving CAR T-cell therapy for LBCL.

Highlighting Advancements in Personalized T-Cell Lymphoma Treatment

Highlighting Advancements in Personalized T-Cell Lymphoma Treatment

Viviana Cortiana, MS4;Yan Leyfman, MD
May 12th 2025
Podcast

Advances in next-generation sequencing and gene expression are reshaping T-cell lymphoma classification and the use of targeted therapies.

Twenty-two of 27 injected tumors across all patients with soft tissue sarcoma in the study showed complete or partial ablation.

Tigilanol Tiglate Exhibits Positive Efficacy in Soft Tissue Sarcoma

Roman Fabbricatore
June 26th 2025
Article

Twenty-two of 27 injected tumors across all patients with soft tissue sarcoma in the study showed complete or partial ablation.

Donor Regulatory T-Cell Therapy to Prevent Graft-Versus-Host Disease

Donor Regulatory T-Cell Therapy to Prevent Graft-Versus-Host Disease

American Society for Transplantation and Cellular Therapy
June 25th 2025
Article

Administering precision-selected donor regulatory T-cell therapy significantly improves GVHD-free, relapse-free survival in patients undergoing allogeneic HCT.