Tag: lymphoma cancer

Nivolumab Granted Accelerated Approval for the Treatment of Classical Non-Hodgkin Lymphoma

The Backstory

On May 14, 2014, the immunotherapy drug nivolumab (Opidivo) received the FDA Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma whose disease relapsed after autologous stem cell transplant and treatment with brentuximab vedotin. Almost exactly two years later, on May 17, 2016, the FDA granted nivolumab accelerated approval for the treatment of people with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin

What is nivolumab?

Nivolumab is the first PD-1 blocking antibody approved for the treatment of a hematologic malignancy. Nivolumab inhibits a protein called PD-1. PD-1 primarily functions as an immune checkpoint, reducing the body’s natural immune response. PD-1 blockers like nivolumab interfere with PD-1 function and allow a person’s own immune system to destroy cancer cells; i.e., PD-1 blockers help the immune system to kill cancer.

Why did the FDA grant nivolumab the accelerated approval designation?

Nivolumab was granted an accelerated approval by the FDA based on results from two clinical trials in adults with relapsed or refractory Hodgkin lymphoma. In one study of 95 patients that had previously undergone autologous stem cell transplantation and brentuximab vedotin, 65% of people responded to nivolumab, with this response lasting almost 9 months on average. The FDA evaluated the safety of nivolumab in 263 patients treated on the second study. As is the case with all accelerated approvals, continued approval will be contingent upon the confirmed clinical results of a randomized phase III trial.

Were there any side effects?

Immune-mediated side effects occurred in 1% to 5% of patients and included rash, pneumonitis (inflammation of the lung), hepatitis (inflammation of the liver), hyperthyroidism, and colitis (inflammation of the intestine). Serious side effects were reported by 21% of patients. Additionally, the FDA issued a “Warning and Precaution” notice for patients who receive nivolumab followed by an allogeneic stem cell transplant. This was due to an increase in complications after allogeneic transplant that may be related to nivolumab. The FDA advises health care professionals to closely follow patients who receive nivolumab followed by allogeneic stem cell transplant for any complications. They have also required further study on the safety of allogeneic HSCT after nivolumab by the drug sponsor.

How can you access nivolumab now?

As an FDA approved drug, nivolumab can be prescribed by any qualified health care professional.

In addition to standard clinical use, at Weill Cornell Medicine we are continuing to study nivolumab and other immunotherapy drugs. For more information about nivolumab or immunotherapy drugs in general, please contact us at 212-746-2919 to make an appointment or with any questions regarding clinical trials or sign up for our newsletter.

The FDA Breakthrough Therapy Designation: A Primer

 

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By Peter Martin, M.D.

The Breakthrough Therapy Designation was introduced as part of the 2012 Food and Drug Administration Safety and Innovation Act and is designed to expedite the development of new treatments for serious conditions like lymphoma. If preliminary evidence from clinical trials demonstrates that a new drug represents a significant improvement over currently available therapies, the drug developer (also called the Sponsor) may request a Breakthrough Therapy Designation.

If the FDA agrees with the Sponsor and grants the designation, they will subsequently commit to providing additional resources to the development and review process.  Practically this means  more frequent meetings and communications with senior FDA officials, and aid in designing more efficient clinical trials. Although the Breakthrough Therapy Designation does not make a new drug available, early experience with the program suggests that it can shave years off of the typical development process.

Since 2012, the Sponsors of 342 treatments have applied for this status, with 111 receiving the designation. Of the treatments that have received the designation 42 have received full approval. In 2016 pembrolizumab received the designation for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma and venetoclax received it in combination with rituximab to treat patients with relapsed/refractory chronic lymphocytic leukemia. Previously nivolumab, idelalisib, ofatumumab, obintuzumab, and ibrutinib all received the Breakthrough Therapy Designation for different lymphoma indications.

Despite the success of the program there are several points to keep in mind. The FDA’s definition of “breakthrough” is very different from its interpretation by lay persons and the media. The FDA’s definition refers to a drug that in the early stages of development has shown the potential for an improvement in patient care. It is not a guarantee of the approval or long-term success of the treatment.

As the FDA and Sponsors gain additional experience with the program we are likely to see some changes, including the number of applications and the cost of requesting a Breakthrough Therapy Designation. We are also likely to witness some unintended consequences, including investments by venture capitalists and opaque marketing strategies. When in doubt a patient should consult a physician about the usefulness of any treatment.

At the Weill Cornell Lymphoma Program, we are interested in any program that helps make promising new therapies available to patients as quickly as possible, and so we continue to follow this and other related programs closely. In the next post in the series we will discuss the Fast Track Designation.

Previous Entries in the Primer Series

The FDA Approval Process

Ask the Doctor: Lisa Roth, MD on Lymphoma in Adolescents and Young Adults

Lisa Roth, MD
Lisa Roth, MD

Every year nearly 70,000 adolescents and young adults (AYAs) are diagnosed with cancer in the United States. Of these, lymphoma is the most common. Teenagers and young adults with lymphoma have different needs than other cancer patients. Treatment can affect your education, career, fertility, and independence, which can be challenging for both patients and their families. Because of this, adolescents and young adults with lymphoma often feel lost – not quite fitting in at pediatric or adult treatment centers.

On May 17th at 6pm, Dr. Lisa Roth, Director of the Adolescent and Young Adult Lymphoma Program at Weill Cornell will present on the challenges faced by these patients. Her talk titled, “Updates on Lymphoma and Treatment Options for Adolescents and Young Adults”, is part of the Lymphoma Research Foundation’s, ‘Ask the Doctor Survivorship Program’.  This event will take place at Gilda’s Club, New York City.

Dr. Roth will answer questions and discuss the following topics:

  • How lymphoma is different for adolescents and young adults
  • Navigating treatment options
  • Understanding fertility preservation
  • Coping with side effects
  • Life after lymphoma treatment

This program is free-of-charge and dinner will be provided. Pre-registration is required. Full details are below:

Three Easy Ways to Register

Call: 800-500-9976
Email:  mspellman@lymphoma.org
Web: Click here

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