FDA expedites approval of two new breast cancer treatments
The U.S. Food and Drug Administration (FDA) has approved two new kinds of breast cancer treatments, one targeting HER2-positive cancers and a second for metastatic triple-negative breast cancer. The FDA notes approval for both treatments was expedited due to the novel coronavirus pandemic.
“As part of FDA’s ongoing and aggressive commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease,” says Richard Pazdur, director of the FDA’s Oncology Center for Excellence. “At this critical time, we continue to expedite oncology product development.”
On April 17 the FDA approved a treatment using a new drug called Tukysa (tucatinib). The approval is for Tukysa to be administered in combination with chemotherapy for patients suffering metastatic HER2-positive breast cancer.
The approval is not for Tukysa as a first-line therapy. Instead, patients must have received at least one prior anti-HER2 treatment before commencing Tukysa.
The approval was based on recently published Phase 3 clinical trial data showing positive results from the novel combination treatment. In particular, the treatment offers hope to those patients with brain metastases, an aggressive form of the disease with very low survival rates.
“Tukysa was approved four months prior to the FDA goal date, providing an example of this commitment and showing how our regular work in reviewing treatments for patients with cancer is moving forward without delay,” says Pazdur.
On April 22 the FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy). This therapy is targeted at patients with a particularly aggressive form of breast cancer known as triple-negative breast cancer.
Trodelvy comes with a relatively severe set of potential side effects, so the FDA approval only allows the therapy to be administered to patients following the failure of at least two other available therapies.
The Trodelvy application was also only granted under the provision of what is called "accelerated approval." This means further clinical trials or clinical data will be necessary before a full approval, however, the drug may be administered widely based on the criteria it is, “reasonably likely to predict a clinical benefit to patients” suffering from serious conditions with unmet medical needs.
“Chemotherapy has been the mainstay of treatment for triple-negative breast cancer,” says Pazdur. “The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy.”
As with the Tukysa case, Trodelvy’s approval was expedited due the FDA’s commitment in bringing oncology treatments more rapidly to market during the coronavirus pandemic.