“We are another step closer to having the first FDA approved therapy for peanut allergy; this is truly a groundbreaking development. Patients and their families have been waiting for this for many years and will be eagerly awaiting the FDA’s final decision.” – David M. Lang, MD, FAAAAI

MILWAUKEE (PRWEB)
September 13, 2019

The Allergenic Products Advisory Committee of the Food and Drug Administration (FDA) met today and voted, based on the available safety and efficacy data, to recommend approval of a standardized oral immunotherapy (OIT) product for peanut allergy. The brand name is expected to be Palforzia, but it was previously referred to as AR101.

The FDA would require a Risk Evaluation and Mitigation Strategy (REMS) to be developed to help ensure the benefits of Palforzia outweigh the risks, and to put additional safeguards in place for patients. The REMS would be in addition to a “black box” warning, the FDA’s most stringent label, in the prescribing information.

While the FDA still needs to complete its review of the product and announce a final decision, the American Academy of Allergy, Asthma & Immunology (AAAAI) seeks to share important information about OIT to help patients and families understand the current state of this therapy.

“This is the first potential treatment for any type of food allergy to be recommended for FDA approval,” said AAAAI President David M. Lang, MD, FAAAAI, who is also Chair of the Allergy/Immunology Department in the Respiratory Institute at Cleveland Clinic. “After today’s meeting, we are another step closer to having the first FDA approved therapy for peanut allergy; this is truly a groundbreaking development. Patients and their families have been waiting for this for many years and will be eagerly awaiting the FDA’s final decision.”

As everyone awaits the FDA’s final decision, here are some factors peanut allergic patients and their families should be aware of when considering OIT:

How OIT Works

OIT refers to feeding an allergic individual an increasing amount of an allergen with the goal of increasing the threshold that triggers a reaction.

For example, Palforzia or AR101 is a capsule filled with peanut powder and can be mixed into food. By taking it, patients are exposed to controlled doses of peanut protein, with the dose gradually increasing over time. Ideally the higher doses will eventually induce a level of tolerance sufficient to prevent severe allergic reactions after accidental exposure to peanut.

A Treatment, Not a Cure

OIT is not a cure. It is likely that most allergic patients receiving OIT must remain on it indefinitely, and patients must continue to avoid dietary exposure to the allergen and continue carrying auto-injectable epinephrine.

Shared Decision Making between Patients, Families and Physicians is Crucial

OIT will not be right for every patient. It is not a “one size fits all” approach. How to predict which individuals will respond to OIT and which individuals will be at highest risk of side effects has not been clearly determined, and there are many other important questions about OIT that require ongoing study.

The AAAAI encourages patients and families to engage with an allergist/immunologist to discuss the risks, benefits, and alternatives of OIT and all other emerging treatments for food allergy. Ultimately, the choice of treatment, including that of active non-intervention, will be based on individual and family factors after careful discussion with one’s physician.

“Patients and their families will need to understand the realities of these new therapies. As physicians, we must invest the time to explain the potential for benefit compared with the potential for harm/burden, and permit patients and families to express their values and preferences, allowing them to participate in the medical decision making process to determine whether they desire to proceed with food oral immunotherapy,” said Dr. Lang.

Learn more about the current state of oral immunotherapy at the AAAAI’s website, aaaai.org.

The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has nearly 7,000 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

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“The RSSearch Registry is a gold mine of data, diligently gathered by dedicated providers across the globe, to provide valuable insight into real-world outcomes of SRS/SBRT treatments. This is exemplified by the significant outcome studies published from this data,” stated Anand Mahadevan, MD.

SAN MATEO, Calif. (PRWEB)
September 13, 2019

The Radiosurgery Society (RSS), a non-profit organization of medical professionals dedicated to advancing the science and clinical practice of stereotactic body radiotherapy (SBRT) and radiosurgery (SRS), announced today that its RSSearch® Patient Registry has surpassed 25,000 patient cases treated with SRS/SBRT. The breadth of patient data entered into the multi-institutional registry makes it by far the largest and most robust live database of its kind in the field of SRS/SBRT managed by a professional medical society.

“The RSSearch Registry is a gold mine of data, diligently gathered by dedicated providers across the globe, to provide valuable insight into real-world outcomes of SRS/SBRT treatments. This is exemplified by the significant outcome studies published from this data. For instance, our paper “Stereotactic Body Radiotherapy for Liver Metastasis” has been reported as one of the top 3 most cited articles by the Journal of Radiation Oncology since 2018, providing useful data for patients and providers on the usefulness of SBRT in difficult situations,” stated Anand Mahadevan, MD, Professor and Chairman, Radiation Oncology at Geisinger Health, Geisinger Cancer Institute, Danville, PA.

The RSSearch Patient Registry is an observational registry established to standardize data collection from patients treated with SRS/SBRT. It was initially conceptualized and designed in 2005 by a Clinical Advisory Board comprised of radiation oncologists, neurosurgeons, medical oncologists and medical physicists to provide a method to collect standardized data on the use of SRS/SBRT treatment practices and outcomes to help determine the most effective clinical use of SRS/SBRT.

“Having a comprehensive resource such as RSSearch, which includes both clinical and radiation planning data points has enabled our faculty and residents work on several projects some of which have yielded very interesting findings,” commented Madhur Garg, MD, Clinical Director of Radiation Oncology, Director of Montefiore-Einstein’s Proton Therapy Program and Co-Director of Stereotactic Radiation Therapy Program at Montefiore Medical Center, Bronx, NY.

Data from the RSSearch Patient Registry has fueled 15 publications to date, including a recent publication by Raj Singh et al in the July 2019 issue of the American Journal of Clinical Oncology titled, “Clinical Outcomes Following Stereotactic Body Radiation Therapy (SBRT) for Stage I Medically-Inoperable Small-Cell Lung Carcinoma: A Multi-Institutional Analysis from the RSSearch Patient Registry.”

“The RSSearch® Patient Registry has enabled Sir Charles Gairdner hospital to collect clinical data for SRS/SBRT patients treated at our facility in Australia and has allowed clinicians and research staff to analyse patient and treatment data and to link this with patient-reported outcomes and treatment results. We have already examined our experience treating patients with localised prostate cancer and have published results. Participating in the Registry has also provided the opportunity to evaluate the effectiveness of our local patient management practices and helped us develop data-driven treatment guidelines. The process has been a huge help in working towards prospective clinical trials,” stated Tammy Corica, PhD, Clinical Trials Manager, Radiation Oncology Clinical Trials & Research Unit, Sir Charles Gairdner Hospital, Nedlands, Australia.

The RSSearch database collects information including patient demographics, lesion characteristics, treatment practices and outcome information including local control, disease progression, survival, toxicity and patient-reported quality of life information. Aggregate data analysis has resulted in several publications on clinical outcomes for radiosurgery treatment of lung tumors, liver metastases, metastatic brain tumors, recurrent head and neck cancer and prostate cancer.

The RSSearch Registry is managed by the RSS and the RSSearch Clinical Advisory Committee, made up of professionals involved in the management and care of patients treated with SRS/SBRT. The registry currently has 26 active sites and more than 80 trained users. Participation in the registry is voluntary and all centers treating patients with SRS/SBRT clinically are encouraged to participate. RSSearch is listed on ClinicalTrials.gov (Identifier (NCT number): NCT01885299).

Interested centers should contact Jan Jenkins, RN, Clinical Program Manager at the Radiosurgery Society at jjenkins@therss.org.

About The Radiosurgery Society®

The Radiosurgery Society (RSS) – a non-profit, independent, multi-disciplinary organization of surgeons, radiation oncologists, physicists, and allied professionals, who are dedicated to advancing the science and clinical practice of radiosurgery. Originally formed in 2002 and becoming 501(c)(6) in 2008, the Radiosurgery Society today (http://www.therss.org) represents approximately 700 members who perform stereotactic body radiotherapy and radiosurgery in hospitals and freestanding centers throughout the world.

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