FDA Approves Single-Dose, Intravenous Paclitaxel Biosimilar for Breast Cancer

FDA

The FDA has approved a single-dose, generic formulation of paclitaxel (Abraxane), comprising paclitaxel protein-bound particles (albumin-bound), for intravenous use in patients with metastatic breast cancer.^1,2

The regulatory decision, which was released on October 8, 2024, marks the first FDA approval of an abbreviated new drug application to the reference product, and supports the launch of the lyophilized powder for injection by the drug’s co-developer, Sandoz.

“An estimated 168,000 women in the US are living with metastatic breast cancer. [Although] rare, men can also develop metastatic breast cancer. This milestone is another proof point of our commitment to provide access to life-changing medicines for all who need them,” Keren Haruvi, the president of Sandoz North America, stated in a news release.1

Paclitaxel protein-bound particles for injectable suspension is a microtubule inhibitor developed by Sandoz in partnership with Jiangsu Hengrui Pharmaceuticals Co. The lyophilized powder consists of 100 mg of paclitaxel formulated as albumin-bound particles in a single-dose vial for reconstitution.1,2

The agent was initially FDA approved in January of 2005 for the treatment of patients with metastatic breast cancer who have progressed on prior chemotherapy combination treatment for metastatic disease or experienced disease relapse within 6 months of receiving adjuvant chemotherapy. The label notes that an anthracycline agent should be included in prior regimens unless clinically contraindicated. This approval was supported by data from a randomized, comparative study of 460 patients with metastatic breast cancer evaluating standard paclitaxel, along with 2 single-arm, open-label studies made up of 106 participants between them.

In addition to breast cancer, the biosimilar is indicated for locally advanced or metastatic non–small cell lung cancer as a first-line treatment in combination with carboplatin or in patients who are not eligible for curative surgery or radiation therapy; or in metastatic adenocarcinoma of the pancreas as first-line treatment alongside gemcitabine.

The recommended dose of the injectable formulation for patients with metastatic breast cancer is 260 mg/m2over 30 minutes every 3 weeks. According to the black-box warning in the drug’s labeling, paclitaxel protein-bound particles for injectable suspension should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3 ; it is not recommended for patients with an aspartate aminotransferase level greater than 10 x ULN; or bilirubin counts greater than 5 x ULN. Additionally, the starting dose should be reduced for patients with moderate to severe hepatic impairment. Doses can be reduced or discontinued as needed.

Following administration, patients should be monitored for potentially severe neutropenia, which may cause infection or sepsis, and complete blood cell counts should be obtained from all patients.

The most common adverse effects reported in at least 20% of patients with metastatic breast cancer include alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea.

References

1. Sandoz US launches generic paclitaxel in single-dose vial, further expanding US oncology portfolio. News Release. Sandoz. October 11, 2024. Accessed October 11, 2024. https://www.sandoz.com/sandoz-us-launches-generic-paclitaxel-single-dose-vial-further-expanding-us-oncology-portfolio/
2. Paclitaxel protein-bound particles for injectable suspension (albumin-bound). Prescribing information. Sandoz; January 2024. Accessed October 11, 2024. https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents/Paclitaxel%20PI.pdf