The United States Food and Drug Administration (FDA) recently approved brentuximab vedotin in combination with chemotherapy as a first-line treatment for people with advanced-stage classical Hodgkin lymphoma.
Also known as Adcetris, brentuximab vedotin is an antibody drug conjugate that targets the CD30 protein present on lymphoma cells and delivers a toxin designed to promote cancer cell death. The drug has been previously approved to treat systemic anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma that has returned after prior therapy.
The FDA’s approval follows the encouraging results of the phase III ECHELON-1 clinical trial, presented at the 2017 American Society of Hematology (ASH) Meeting and Exposition and published in the New England Journal of Medicine. The trial, which was open at Weill Cornell Medicine and NewYork-Presbyterian Hospital, compared standard therapy with adriamycin, bleomycin, vinblastine and dacarbazine (ABVD) versus adriamycin, vinblastine and dacarbazine plus brentuximab vedotin (A+AVD).
Of the 1,300+ enrolled patients, those receiving A+AVD were demonstrated to be 23 percent less likely to experience disease progression, a need for additional therapy, or death, as compared to the cohort receiving the standard of care therapy.
“ABVD has been the standard therapy for a couple decades because it works really well, but it’s great to have new treatments available for people with Hodgkin lymphoma,” said Peter Martin, Chief of the Lymphoma Program. “I’m proud that we were able to offer this treatment at Weill Cornell a long time ago through the ECHELON-1 trial. Like any treatment, the A+AVD combination may not be right for everyone and requires consideration of side effects, like infection risk and neuropathy. Decisions between patients and physicians regarding the best treatment should follow an open discussion of the evidence.”
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.
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.