Jazz Pharmaceuticals and PharmaMar have announced US approval of Zepzelca (lurbinectedin) for the treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy, offering a new second-line treatment option.
The drug was cleared under accelerated approval based on overall response rate (ORR) and duration of response seen in mid-stage studies, so its continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
For now, clearance is based on monotherapy clinical data from a Phase II, open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.
The data showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 35% and a median duration of response of 5.3 months.
“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,” said Bruce Cozadd, chairman and Jazz' chief executive.
“While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.”
“For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing SCLC,” added Dr Jeff Petty, oncology specialist, Wake Forest Baptist Health.