FDA Approves New Drug That Could Slow Breast Cancer Progression

The U.S. Food and Drug Administration (FDA) has approved new targeted therapy for certain patients with advanced breast cancer whose disease has progressed despite hormone therapy. The approval gives breast cancer patients another option for one of the most common forms of advanced breast cancer.

The treatment, called REVTORPYK (gedatolisib), from Celulicity, is approved for adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors do not have a PIK3CA mutation. While those terms may sound technical, this subtype accounts for the majority of breast cancer diagnoses, and many patients eventually need additional treatment when hormone therapy is no longer effective.

Impressive Trial Results

The FDA’s decision was based on results from the phase 3 VIKTORIA-1 clinical trial. Patients who received the drug alongside the breast cancer drugs fulvestrant and palbociclib (Ibrance) stayed free from disease progression for a median of 9.3 months, compared with 2 months for patients who received fulvestrant alone. Overall, the combination reduced the risk of disease progression or death by 76 percent.

Why Experts Are Encouraged

Seattle oncologist, Sara Hurvitz, MD, senior vice president of the Clinical Research Division at Fred Hutchinson Cancer Center and co-principal investigator of the VIKTORIA-1 trial, told OncLive the approval addresses a significant unmet need for patients with this type of advanced breast cancer.

“For patients with HR-positive/HER2-negative locally advanced or metastatic breast cancer, there is an urgent need for new treatment options that can meaningfully increase the likelihood of survival without disease progression or death. With the approval of REVTORPYK, oncologists now have an effective new treatment option for these patients.”

What Patients Should Know

REVTORPYK is used in combination with existing breast cancer medications and works by targeting multiple pathways that cancer cells use to grow. Researchers believe that broader approach may help overcome treatment resistance that can develop over time.

As with many cancer therapies, the treatment can cause side effects. The most common include mouth sores, nausea, rash, fatigue and elevated blood sugar. Patients taking the medication will be monitored throughout treatment to help manage these effects. Celcuity expects REVTORPYK to become commercially available later this year.

Adapted in part from reporting by OncLive, an MJH Life Sciences publication.