Over the past two decades, the U.S. Food and Drug Administration (FDA) has approved more than two dozen unique drugs for treating patients with breast cancer, across more than 40 indications. During that time, the San Antonio Breast Cancer Symposium^® has offered attendees a valuable forum for discussing these regulatory decisions and learning about the approval process firsthand from FDA representatives.

At the 2024 SABCS^®, experts from the FDA will share insights on recent approvals during FDA Special Session: New Drug Approvals, Tuesday, December 10, from noon to 1:45 p.m. CT in Stars at Night Ballroom 3-4 at the Henry B. Gonzalez Convention Center.

Laleh Amiri-Kordestani, MD, Director of FDA Division of Oncology 1 in the Center for Drug Evaluation and Research’s Office of Oncologic Diseases, and Eric Winer, MD, Alfred Gilman Professor of Medicine and Pharmacology and Deputy Dean of Cancer Research at Yale School of Medicine, will moderate the session, which was developed in close collaboration with SABCS^® Co-Director Virginia G. Kaklamani, MD.

Adjuvant ribociclib

The session will begin with a presentation by Jennifer Gao, MD, Associate Director for Education at the FDA Oncology Center of Excellence. She will review data and regulatory considerations that led to the September 2024 approval of ribociclib with an aromatase inhibitor, based on the NATALEE trial, for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.

Dr. Winer said that although this ribociclib approval is broad, the approved regimen may not be the right treatment for every eligible patient. While regulatory approvals are one of the key components that inform choice of treatment and facilitate insurance reimbursement for new treatments, approval does not translate to universal applicability for all patients. Treatments must be individualized and optimized for each patient.

Inavolisib approval

Suparna Wedam, MD, Clinical Reviewer at the FDA Office of Oncologic Diseases, will summarize the FDA thought process and data supporting the October 2024 approval of inavolisib with palbociclib and fulvestrant based on the INAVO120 trial for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Dr. Winer noted that the approval of the inavolisib combination was based on progression-free survival (PFS), not overall survival (OS).

“While recent FDA approvals include treatments that were approved for treating patients with metastatic breast cancer based on PFS as an endpoint, OS is ultimately the gold standard and what we strive for,” he said. “In particular, when one is adding a third drug to a combination, one can never be certain that the combination is better than sequential administration in the absence of OS.”

In addition to hearing from FDA representatives about their decision-making process for this approval, Dr. Winer said it will be interesting to hear from audience members about how they will use that information to make patient-focused decisions.

Monitoring of ovarian toxicity during clinical trials

The session’s final presentation, by Antonio C. Wolff, MD, Professor of Oncology at Johns Hopkins University, will focus on considerations for monitoring ovarian toxicity in oncology clinical trials and patients with cancer.

“Ovarian toxicity is often not adequately assessed in clinical trials of anti-cancer agents, leaving a critical information gap for patients making therapy decisions,” Dr. Amiri-Kordestani said.

Although integrating ovarian toxicity measures into trial design adds complexity and burden to trial resources, this issue is important to patients and can no longer be ignored, she said.

Panel discussion

The session will also include a discussion with the moderators, speakers, patient advocate Victoria Goldberg of New York City, and Tiffany Ricks, PhD, and Mallorie Fiero, PhD, from the FDA Office of Oncologic Diseases.

In addition to the session topics, Dr. Amiri-Kordestani noted that one of the key regulatory perspectives that will be highlighted is the ongoing challenge of ensuring diversity in oncology clinical trials.

She said that the FDA Oncology Center of Excellence Equity Program, which is addressing how access to clinical trials can be improved for historically underrepresented populations, will be discussed in the context of the trials and the postmarketing commitments for broadening access to treatments for diverse populations.

Dr. Amiri-Kordestani hopes audience members take home the message that this is a pivotal moment in breast cancer treatment, with significant advancements in both early-stage and metastatic disease management.

“I hope this session provides attendees with a deeper understanding of the regulatory considerations that guide these approvals and the broader implications for clinical practice,” Dr. Amiri-Kordestani said. “Ultimately, the goal is to ensure that patients have access to the best possible treatments, including reproductive health.”