FDA approved Etopophos (etoposide phosphate) for Refractory Testicular Tumors and Small Cell Lung CancerFDA approved new form of chemotherapy drug for two cancers

Etopophos is a topoisomerase inhibitor. It is a prodrug of etoposide.

Etopophos is indicated for the treatment of patients with refractory testicular tumors, in combination with other chemotherapeutic drugs. It is also indicated for the first-line treatment of patients with small cell lung cancer, in combination with cisplatin.

For refractory testicular tumors, the recommended dose is 50 to 100 mg/m² per day administered intravenously over 5 minutes to 3.5 hours on days 1 through 5, or 100 mg/m² administered intravenously over 5 minutes to 3.5 hours on days 1, 3, and 5 of each 21-day or 28-day cycle. For small cell lung cancer, the recommended dose is 35 mg/m² per day administered intravenously over 5 minutes to 3.5 hours for 4 days, or 50 mg/m² per day for 5 days. Do not give by bolus injection. In patients with creatinine clearance 15 to 50 mL/min, administer 75% of the recommended dose. Data are not available for patients with creatinine clearance less than 15 mL/min.

Study 1 was a multicenter trial in patients with previously untreated small cell lung cancer, randomized (1:1) to receive either etoposide phosphate (80 mg/m²/day) plus cisplatin (20 mg/m²/day) for 5 days, or etoposide (80 mg/m²/day) plus cisplatin (20 mg/m²/day). The major efficacy outcome measure was objective response rate (ORR). Among 121 patients enrolled, the median age was 64 years, 65% were male, 89% were White, and ECOG performance score was 0 to 2. The overall response rate was 61% (95% CI: 47, 73) for etoposide phosphate plus cisplatin, and 58% (95% CI: 45, 71) for etoposide plus cisplatin.

Etopophos is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products. Extravasation may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Co-administration with warfarin can result in elevated international normalized ratio (INR); measure INR frequently. Etopophos is a cytotoxic drug; follow applicable special handling and disposal procedures. Use gloves to minimize risk of dermal exposure.

Etopophos provides an alternative formulation of etoposide for the treatment of refractory testicular tumors and small cell lung cancer. In small cell lung cancer, it is used as first-line treatment in combination with cisplatin. Its efficacy appears comparable to etoposide in the studied population.