US FDA approves Taxotere injection concentrate formulation

Sanofi-aventis announces that the US FDA has approved a one-vial formulation of its chemotherapeutic agent Taxotere (docetaxel) injection concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

Introduced more than 14 years ago, Taxotere is approved by the FDA for use in treating patients at specific stages of five types of cancer: metastatic and adjuvant breast cancer, metastatic androgen independent prostate cancer, advanced non-small cell lung cancer, advanced gastric adenocarcinoma and locally advanced squamous cell carcinoma of the head and neck.

"This new formulation underscores the commitment sanofi-aventis has made to Taxotere and to healthcare professionals. We look forward to adding this formulation of Taxotere to the arsenal of oncology products sanofi-aventis offers to the cancer community," said Paul Hawthorne, vice president and head of the Oncology Business Unit at sanofi-aventis US.

The most common adverse reactions across all Taxotere indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions and myalgia.

Previously, Taxotere was available to health care professionals in a two vial formulation – one vial containing docetaxel concentrate and the other with the diluent. The one-vial Taxotere eliminates the need for the initial dilution step with the diluents, and now at 20mg/ml concentration, is ready to be added directly into the infusion solution. It is expected to help simplify preparation by eliminating the dilution step.

With one-vial Taxotere, the pharmaceutical ingredients of Taxotere and the one hour IV infusion administration to the patient remain the same.

Taxotere has been used worldwide to treat more than 1.5 million patients, 100,000 of whom were participants in clinical trials.