Jazz Pharmaceuticals announced that its lung cancer drug Zepzelca failed to meet the main goal of improving overall survival in a late-stage study. The company shared the trial results with the U.S. Food and Drug Administration and will discuss next steps regarding post-marketing requirements for the drug’s second-line indication.

Background

Zepzelca already holds accelerated approval from the FDA as a second-line treatment for advanced small cell lung cancer (SCLC), an aggressive form of lung cancer that can spread to other parts of the body, including the bone marrow. The late-stage confirmatory trial tested the drug both as a single therapy and in combination with chemotherapy.

In the study, patients treated with Zepzelca alone lived a median of 8.7 months, while those on the combination therapy lived 10.9 months, compared with 10.7 months for patients in the control group. The FDA had previously approved Zepzelca in combination with Roche’s immunotherapy Tecentriq as a maintenance treatment for adult patients with extensive-stage SCLC whose disease has not progressed after initial chemotherapy.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.