Category: Lymphoma News

FDA Approves Copanlisib for Certain Types of Follicular Lymphoma

The United States Food and Drug Administration (FDA) recently granted accelerated approval to copanlisib for treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior lines of therapy. Copanlisib is a kinase inhibitor that works by blocking some of the enzymes responsible for cancer cell growth.

The FDA’s decision is based on favorable safety and efficacy results in over 100 patients around the world as part of the CHRONOS-1 clinical trial.

Instead of having to wait years to learn whether a drug actually extends survival for cancer patients, accelerated approval enables the FDA to more quickly approve drugs that fulfill an unmet clinical need for serious conditions. Scientists look to measure surrogate or intermediate clinical endpoints – like tumor shrinkage, for example – that indicate whether a drug is reasonably likely to predict clinical benefit.

As a condition of accelerated approval, a randomized control (comparison) trial will be required to verify the clinical benefit of copanlisib before it can move on to help relapsed follicular lymphoma patients whose treatment options are often limited.

Dr. Sarah Rutherford Examines Necessity of Bone Marrow Biopsy in Follicular Lymphoma Clinical Trials

This is an excerpt of a recent Medscape article in which Dr. Sarah Rutherford comments on her research published in the British Journal of Haematology. Read the full story here.

Clinical trials in patients with follicular lymphoma (FL) mandate that patients undergo bone marrow biopsies (BMBs) at baseline and at subsequent points following treatment in order to monitor response. But how necessary are they?

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Dr. Sarah Rutherford

The biopsies are unnecessary in most patients, argue researchers reporting results from a  retrospective analysis of 99 patients with FL enrolled across 32 clinical trials at Weill Cornell Medical College. The study found that the mandatory BMBs resulted in response assessment change in at most 1% of patients and so concluded that they were not needed.

“In our patient-centered approach to care, we find that these biopsies are painful and anxiety-provoking. The procedures take time, add to healthcare costs, and are a hindrance for patients to participate in clinical trials,” corresponding author, Sarah Rutherford, MD, medical oncologist at Weill Cornell Medicine and NewYork-Presbyterian, New York City, told Medscape Medical News.

“In routine clinical practice, we do not often do bone marrow biopsies in follicular lymphoma patients. Removal of this barrier can contribute significantly to increasing patient interest in clinical trials, which can provide them access to novel and promising therapies,” she added.

FDA Approves Expanded Use of Ibrutinib for Chronic GVHD

Ibrutinib, a BTK inhibitor commonly used to treat lymphoma types like chronic lymphocytic leukemia (CLL) and mantle cell lymphoma, has been approved by the United States Food and Drug Administration (FDA) for treatment of adults with chronic graft versus host disease (cGVHD).

Ibrutinib Pills in Hand

GVHD can occur following a stem cell or bone marrow transplant from a related or unrelated donor, also known as an allogeneic transplant. When the immune cells from the graft (donor) are infused into the body of the host (patient), they may recognize the host’s native cells as foreign and try to destroy them. While some cases of GVHD are life threatening, chronic cases tend to generate to more mild symptoms, like dry eyes and mouth, fatigue, and muscle weakness and stiffness.

Ibrutinib becomes the first FDA-approved treatment of cGVHD following clinical trials demonstrating durable safety and effectiveness in patients whose symptoms were resistant to prior corticosteroid treatment administered for immune system suppression.