FDA Reviewing Oral Paclitaxel Combo as Metastatic Breast Cancer Treatment



paclitaxel under review

The U.S. Food and Drug Administration (FDA) is reviewing a new drug application from Athenex seeking approval of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer.

The application has been granted priority review, and the FDA is expected to make a decision no later than Feb. 28, 2021. The FDA, according to Athenex, it is not currently planning to hold an advisory committee meeting to discuss the application.

“We are working diligently with the FDA on this Priority Review to bring Oral Paclitaxel to patients with metastatic breast cancer as quickly as possible,” Rudolf Kwan, MD, Athenex’s chief medical officer, said in a press release.

“We are delighted to have achieved this major milestone for Athenex,” added Johnson Lau, MD, chairman and CEO of Athenex. “We continue to finalize our commercial preparations to ensure a successful launch of Oral Paclitaxel, if approved.”

Paclitaxel is a widely used chemotherapy agent that works by disrupting cell division, which prevents cancer cells from growing. When paclitaxel alone is taken by mouth, it is not absorbed very well by the body; therefore, medication is normally given intravenously (directly into the bloodstream).

Encequidar was discovered by Athenex through the Orascovery Platform, which Athenex licensed from original developer Hanmi Pharmaceuticals.

When paclitaxel is taken orally in combination with encequidar the chemotherapy is absorbed much more effectively. As such, the Oral Paclitaxel combination therapy aims to provide the same therapy with a more convenient administration route.

“Intravenous (IV) Paclitaxel is a foundational chemotherapy in multiple tumor types and we plan to invest in broadening the label and uses for Oral Paclitaxel,” Kwan said.

Athenex’s application to the FDA is supported by data from a multicenter, open-label, randomized, Phase 3 clinical trial (NCT02594371), which Athenex sponsored. The trial enrolled 402 people with metastatic breast cancer (breast cancer that has spread elsewhere in the body). Participants were assigned randomly to treatment with either Oral Paclitaxel or IV paclitaxel.

Topline results showed that significantly more participants given Oral Paclitaxel responded to treatment (36% vs. 24%). There were indications of benefits to survival, though these results were not “mature.” That means so many participants in the study are still alive that it is mathematically impossible to make accurate calculations about survival.

The oral therapy also was associated with a lower rate of certain side effects, including neuropathy (nerve-related weakness and pain, most often in the hands and feet), though there were higher rates of gastrointestinal side effects with the oral treatment.

“We see Oral Paclitaxel as a potentially important alternative to IV infusions, especially during the current pandemic, as it may allow cancer patients to take the oral chemotherapy at home. We believe the Oral Paclitaxel program validates our broader Orascovery platform, and we are committed to applying the technology to convert other IV chemotherapies into oral agents,” Lau said.

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