FDA gives accelerated approval to Zepzelca for the treatment of metastatic small cell lung cancer. Jazz Pharma + PharmaMar

Jazz Pharmaceuticals plc announced along with its partner PharmaMar that the FDA approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The FDA approval of Zepzelca is based on monotherapy clinical data from an 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, which appeared in The Lancet Oncology May 2020 issue, showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 35 percent and a median duration of response of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC)).

See- “Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial”- JoséTrigo MD,Vivek Subbiah MD, Prof Benjamin Besse MD,VictorMoreno MD, RafaelLópez MD,María AngelesSala MD, et al. https://doi.org/10.1016/S1470-2045(20)30068-1.