December 4, 2023

First of Its Kind: Oncology Pharmacovigilance Clinic

Multidisciplinary care for patients with immune-related adverse events


By Cassandra Calabrese, DO


Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy

The cancer treatment landscape was forever changed in 2011 with approval of the first checkpoint inhibitor, nivolumab. These drugs rev up the immune system to target tumor cells and have provided options for durable treatment responses for patients with previously untreatable cancers.

Unfortunately, due to their mechanism, they are attended by a spectrum of adverse events that mimic immune-mediated diseases (such as rheumatoid arthritis and colitis), and these are called immune-related adverse events (irAEs). With the increasing approval of new checkpoint inhibitor therapies for an ever-expanding list of indications, we are seeing a rise in referrals for irAE diagnosis and management in rheumatology and other specialties.

In 2017, Cleveland Clinic created a multidisciplinary monthly tumor board, which continues to serve as a venue for discussion of challenging cases, review the extant literature and receive input on interprofessional management. In the past year, almost on- third of the cases discussed at irAE tumor board are rheumatologic irAE cases.


Major academic centers have varying triage and referral processes for care of patients with irAEs. Cleveland Clinic is the first to create a multidisciplinary clinic to serve this purpose. In September 2023, the Oncology Pharmacovigilance Clinic was created in the Taussig Cancer Center under the guidance of Wen Wee Ma, MBBS, the inaugural Director of the Novel Cancer Therapeutics Center in Taussig. This clinic is in Taussig and occurs one half-day per week. It is staffed by myself, endocrinologist Keren Zhou, MD, and coordinated with Oncology.

Patients with irAEs are often acutely symptomatic, with symptoms interfering with activities of daily living and disrupting their cancer treatment. Many are experiencing irAEs involving multiple systems. For these reasons, it is important there be timely access for their evaluation by Oncology and appropriate subspecialists, and ideally in a coordinated fashion.

The goal of the Pharmacovigilance Clinic is to serve as a space for exactly that, fostering excellent patient care and in-person interactions between subspecialists. This type of clinic for irAE care exists nowhere else in the world, and we are proud to be involved in this ground-breaking endeavor.


After this initial phase, the goal is to introduce additional specialists such as gastroenterology, cardiology and beyond.

Related Articles

How antibody drug conjugates work
February 13, 2024
Real-World Use of Trastuzumab Deruxtecan

Key learnings from DESTINY trials

February 7, 2024
Advances in Bone Marrow Transplant Have Improved Outcomes in Fanconi Anemia

Overall survival in patients treated since 2008 is nearly 20% higher than in earlier patients

February 5, 2024
Haploidentical Bone Marrow Transplant Has Durable Engraftment in Patients With Sickle Cell Disease

Two-year event-free survival comparable to matched sibling donor myeloablative transplant

February 1, 2024
Possibilities of CRISPR Technology (Podcast)

Gene editing technology offers promise for treating multiple myeloma and other hematologic malignancies, as well as solid tumors

January 30, 2024
Gene Therapy Trials Show Positive Results in Sickle Cell Disease and Thalassemia

First-in-human trials of CRISPR-Cas12a gene editing demonstrate safety and meaningful event-free survival

photo of Elekta Esprit Gamma Knife machine
January 26, 2024
The Evolution of Gamma Knife Technology (Podcast)

Improvements enable targeting of brain tumors with single-session, fractionated or neoadjuvant approaches

Disparities in multiple myeloma
January 25, 2024
Major Study Identifies Global Disparities in Drug Toxicity for Multiple Myeloma Treatment

Study of 401,576 patients reveals differences in cancer burdens as well as overall survival

Treating older patients with diffuse large B-cell lymphoma (DLBCL)
January 18, 2024
Trial for Patients 75 and Older with Diffuse Large B-Cell Lymphoma Helps Address Care Inequities

Multiple Cleveland Clinic sites to participate in National Cancer Institute trial comparing treatment regimens for newly diagnosed patients