June 15, 2020 – The U.S. FDA has approved Zepzelca^TM (lurbinectedin), manufactured by PharmaMar and Jazz Pharmaceuticals, to treat adult patients who have metastatic small cell lung cancer (SCLC) and disease progression on or after platinum-based chemotherapy.

SCLC accounts for approximately 15% of all lung cancer diagnoses. It is the most aggressive form of lung cancer, and in almost all instances occurs in individuals who have a history of smoking cigarettes. The cancer’s cells duplicate rapidly and readily spread to other parts of the body (metastasis). In most cases, the condition is not diagnosed until it has become metastatic. This contributes to a poor overall prognosis for patients. An early diagnosis can help extend life, but such circumstances are rare, and most SCLC patients relapse even if they have initial treatment success with chemotherapy.

In a clinical study, Zepzelca achieved an overall response rate of 35% in patients diagnosed with relapsing SCLC. It also delivered a median duration of response of 5.3 months. Recommended dosing is 3.2mg/m² of body surface area administered via intravenous infusion over the course of one hour, once every 21 days. Treatment should be initiated only if the patient’s absolute neutrophil count is at least 1,500 cells/ mm 3 and their platelet count is at least 100,000/mm 3 .

The FDA granted Zepzelca accelerated approval based on overall response rate and duration of response, meaning that continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Zepzelca has launched at a wholesale acquisition cost (WAC) of $6,633 per vial.