FDA to Expedite Review of Novel Drug in Subset of Metastatic Breast Cancer


Investigators are analyzing the novel drug, OP-1250, both as a single-agent treatment option and in combination with Ibrance in patients with recurrent, locally advanced or metastatic ER-positive/HER2-negative breast cancer.

The Food and Drug Administration (FDA) granted a fast track designation to OP-1250, an investigational drug, for the treatment of recurrent, locally advanced or metastatic ER-positive/HER2-negative breast cancer, according to a press release from Olema Pharmaceuticals.

When the FDA grants a drug a fast track designation, it means that the agency and the manufacturer of the drug will maintain frequent communications throughout the development of the treatment. The purpose is to expedite the drug’s development, review and potentially its approval.

Investigators are currently reviewing the safety of OP-1250 across two clinical trials.

One of the early-stage clinical trials is enrolling approximately 30 patients with advanced or metastatic HR-positive, HER2-negative breast cancer. The aim of the study is to identify how many patients treated with OP-1250 in combination with Ibrance (palbociclib) experience dose-limiting toxicities, which are side effects that result in the need for a lower dose of the drug. The investigators also will analyze the number and severity of side effects.

In the second clinical trial, approximately 94 patients are receiving treatment with single-agent OP-1250. Here, the study authors primary focus is to identify the maximum tolerated dose or recommended dose for a phase 2 study of OP-1250 as a monotherapy.

According to the National Cancer Institute, a maximum tolerated dose is the highest dose of a drug or treatment that does not cause unacceptable side effects.

“Receiving fast track designation from the FDA for OP-1250 is an important milestone for the development program and underscores OP-1250’s potential clinical utility to address a significant unmet medical need in women living with advanced ER+/HER2-negative breast cancer,” Dr. Sean P. Bohen, president and CEO of Olema Oncology, said in the release. “We look forward to working closely with the FDA to optimize and expedite the development program, with the goal of making OP-1250 available to patients sooner.”

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