Taxotere

Taxotere (docetaxel) is a chemotherapy drug approved for several indications, including as a single agent for locally advanced or metastatic breast cancer after chemotherapy failure, with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive breast cancer, as a single agent for locally advanced or metastatic non-small cell lung cancer (NSCLC) after platinum therapy failure, with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC, and with prednisone in metastatic castration-resistant prostate cancer. Doses range from 60 mg/m2 to 100 mg/m2 depending on the indication.

Key efficacy findings include a median survival of 9.2 months and a 1-year survival rate of 37%. The overall response rate was 37.9%, with a complete response rate of 2.1%. In some studies, Taxotere demonstrated an overall reduction in the risk of relapse of 25.7% and an overall survival hazard ratio of 0.69. The risk ratio for mortality (Docetaxel: Control) was 0.56 in one study.

Notable safety findings include Febrile Neutropenia at 11% in all tumor types (Normal LFTs) and 26% in all tumor types (Elevated LFTs) with TAXOTERE at 100 mg/m2. Anemia (<8 g/dL) was observed in 31% of all tumor types (Elevated LFTs) and 8% in breast cancer (Normal LFTs) at the same dose. Septic death occurred in 2% of all tumor types (Normal LFTs). There were 538 case reports of hyponatremia from healthcare providers, with 480 being serious. A total of 2172 unique solicited and unsolicited case reports of alopecia were also noted. The drug received approval on December 11, 2015, and May 15, 2020, under Application Number NDA 20-449/S-075.