FDA Approves Single-Dose Paclitaxel Biosimilar for Metastatic Breast Cancer
核心洞察
The FDA has approved the first single-dose, generic formulation of paclitaxel (Abraxane) for intravenous use in metastatic breast cancer (搜索) patients.
This approval supports the launch of the lyophilized powder for injection by Sandoz, aiming to improve access to essential medicines.
The biosimilar is also indicated for non-small cell lung cancer (搜索) and metastatic adenocarcinoma of the pancreas (搜索), expanding its therapeutic use.
The FDA has granted approval for a single-dose, generic version of paclitaxel (Abraxane), specifically paclitaxel protein-bound particles (albumin-bound), administered intravenously for patients diagnosed with metastatic breast cancer (搜索). This regulatory decision, announced on October 8, 2024, marks the first approval of an abbreviated new drug application for this reference product and facilitates the introduction of the lyophilized powder for injection by Sandoz, the drug's co-developer.
Keren Haruvi, President of Sandoz North America, stated, "An estimated 168,000 women in the US are living with metastatic breast cancer (搜索). This milestone is another proof point of our commitment to provide access to life-changing medicines for all who need them."
Therapeutic Indications
Paclitaxel protein-bound particles, a microtubule inhibitor developed by Sandoz in collaboration with Jiangsu Hengrui Pharmaceuticals Co. (搜索), is formulated as albumin-bound particles in a 100 mg single-dose vial for reconstitution. Initially approved in January 2005, it is indicated for metastatic breast cancer (搜索) patients who have progressed on prior chemotherapy or relapsed within 6 months of adjuvant chemotherapy, with the label recommending inclusion of an anthracycline agent unless contraindicated.
Beyond breast cancer (搜索), this biosimilar is also approved for first-line treatment of locally advanced or metastatic non-small cell lung cancer (搜索) in combination with carboplatin, or for patients ineligible for curative surgery or radiation therapy. Additionally, it is indicated for first-line treatment of metastatic adenocarcinoma of the pancreas (搜索) alongside gemcitabine.
Dosage and Administration
The recommended dosage for metastatic breast cancer (搜索) is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks. The drug's labeling includes a black-box warning, advising against administration to patients with baseline neutrophil counts below 1,500 cells/mm3 and cautioning against use in patients with aspartate aminotransferase levels exceeding 10 times the upper limit of normal (ULN) or bilirubin counts exceeding 5 times ULN. Dosage reduction is recommended for patients with moderate to severe hepatic impairment. Adjustments or discontinuation may be necessary based on individual patient response.
Monitoring and Adverse Reactions
Post-administration, patients should be monitored for severe neutropenia (搜索), which can lead to infection or sepsis. Complete blood cell counts are essential for all patients. Common adverse effects reported in at least 20% of metastatic breast cancer (搜索) patients include alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, elevated AST and alkaline phosphatase, anemia, nausea, infections, and diarrhea.