The approval of Zepzelca is for treating metastatic small cell lung cancer in adults whose disease has progressed on or after platinum-based chemotherapy.
The alkylating drug, which is also known as PM1183, is to be administered by an intravenous (IV) infusion delivering a 3.2mg/m2 dose over the course of an hour, which has to be repeated after every 21 days until disease progression or unacceptable toxicity.
Jazz Pharmaceuticals chairman and CEO Bruce Cozadd said: “Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy.
“While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.”
The accelerated approval of Zepzelca was granted by the FDA based on the overall response rate (ORR) and duration of response in an open-label, single-arm study in 105 adult patients with SCLC, who are platinum-sensitive and platinum-resistant and whose disease progressed after treatment with platinum-based chemotherapy.
Zepzelca’s continued approval for the indication could be based upon verification and description of clinical benefit in a confirmatory trial.
The alkylating drug delivered an ORR of 35% and a median duration of response of 5.3 months in the phase 2 monotherapy trial.
Jazz Pharmaceuticals expects the newly approved lung cancer drug to be made commercially available in the US in early July.
The Irish pharma company acquired the US licensing rights for lurbinectedin from the Spain-based PharmaMar in January 2020 in a deal worth up to $1bn, which includes an upfront payment of $200m, regulatory milestone-related payment of up to $250m, and up to $550m in potential commercial milestone payments.
PharmaMar president José María Fernández Sousa-Faro said: “We are pleased to bring a new treatment choice to relapsed SCLC patients.
“The U.S. FDA accelerated approval of Zepzelca underscores its potential to fill an unmet need in this often-overlooked SCLC community.”