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
Recent Videos
A 2-way communication between providers and patients may help facilitate dose modifications to help better manage adverse effects.
Treatment with AML depends on a variety of factors, including stage of treatment, transplant eligibility, and mutational status.
Patients with mantle cell lymphoma who are older and have less fitness may be eligible for regimens that include bendamustine/rituximab.
It may be critical to sequence BCL-2 inhibitors with BTK inhibitors for patients with mantle cell lymphoma in the relapsed/refractory setting.
Reducing the manufacturing time of CAR T-cell therapy may have a big impact on the treatment of patients with mantle cell lymphoma.
Related Content
An indirect comparison supports continuous therapy with zanubrutinib as a valuable treatment option in treatment-naïve CLL or SLL.

Indirect Comparison Favors Zanubrutinib vs Venetoclax Combo in CLL/SLL

Russ Conroy
September 26th 2025
Article

An indirect comparison supports continuous therapy with zanubrutinib as a valuable treatment option in treatment-naïve CLL or SLL.

Experts detailed key advances in myelofibrosis, multiple myeloma, and lymphoma at the Society of Hematologic Oncology 2025 Annual Meeting.

Unraveling Key Blood Cancer Takeaways From the 2025 SOHO Meeting

Francesca Palandri, MD, PhD;Sundar Jagannath, MD;Adam J. Olszewski, MD
September 15th 2025
Podcast

Experts detailed key advances in myelofibrosis, multiple myeloma, and lymphoma at the Society of Hematologic Oncology 2025 Annual Meeting.

Boston’s Best Did Not “Leave the Cannoli” in Battle of Lymphoma Top Trials

Boston’s Best Did Not “Leave the Cannoli” in Battle of Lymphoma Top Trials

ONCOLOGY Staff
September 25th 2025
Article

Two teams of lymphoma experts engage in a face-off competition, showcasing real-world updates, patient cases, and use of ASCT or CAR T-cell therapy.

A panel of clinical pharmacists discussed strategies for mitigating toxicities across different multiple myeloma, lymphoma, and leukemia populations.

Navigating AE Management for Cellular Therapy Across Hematologic Cancers

Tiba Al Sagheer, PharmD, BCOP, BCACP;Rebecca Gonzalez, PharmD, BCOP, FASTCT;Syeda Saba Kareem PharmD, BCOP
August 11th 2025
Podcast

A panel of clinical pharmacists discussed strategies for mitigating toxicities across different multiple myeloma, lymphoma, and leukemia populations.

Regarding safety, treatment-related adverse effects occurred in 93% of patients, with grade 3 or 4 TRAEs occurring in 60%.

Mosunetuzumab Treatment Combo Yields Responses in High-Risk MCL

Tim Cortese
September 21st 2025
Article

Michael Wang, MD, stated that results from this phase 2 trial were tremendous and showed that mosunetuzumab plus polatuzumab vedotin is viable in MCL.

The second takeaway is that the type of responses and efficacy that we have seen with these combinations rival what we have in our standard of care armamentarium.

How Promising Are Immunotherapy Combos in Indolent Lymphoma?

Tim Cortese
September 12th 2025
Article

Lorenzo Falchi, MD, highlighted the most important considerations when using novel immunotherapy combination therapies for patients with indolent lymphoma.