FDA approves Zepzelca for metastatic small cell lung cancer
The FDA granted accelerated approval to lurbinectedin for adults with metastatic small cell lung cancer that progressed on or after platinum-based chemotherapy.
The agency based the approval of lurbinectedin (Zepzelca; Jazz Pharmaceuticals, PharmaMar) — an alkylating drug that binds guanine residues within DNA — on data from the multicenter, open-label, multicohort PM1183-B-005-14 trial, which included 105 patients with metastatic small cell lung cancer who experienced disease progression on or after receiving platinum-based chemotherapy.
Patients received 3.2 mg/m2 IV lurbinectedin every 21 days until disease progression or unacceptable toxicity.
Investigator-assessed overall response rate and duration of response served as the study’s main efficacy outcomes.
Researchers reported an ORR of 35% (95% CI, 26-45) and a median duration of response of 5.3 months (95% CI, 4.1-6.4). ORR as assessed by an independent review committee was 30% (95% CI, 22-40), with a 5.1-month (95% CI, 4.9-6.4) median duration of response.
“Seeing first-hand the aggressive nature of [small cell lung cancer] and knowing that the large majority of those diagnosed will experience relapse, I am excited to see an effective new treatment demonstrating durable responses,” Jeff Petty, MD, oncology specialist at Wake Forest Baptist Health, said in a manufacturer-issued press release. “For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing [small cell lung cancer].”
The most common adverse events associated with lurbinectedin included myelosuppression, fatigue, increased creatinine, increased alanine aminotransferase, increased glucose, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.
FDA reviewed this drug application under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international agencies. The application also had previously received orphan drug designation and priority review.