By Christy Santhosh
June 12 (Reuters) – Jazz Pharmaceuticals said on Friday its lung cancer drug Zepzelca failed to meet the main goal of improving overall survival in a late-stage study, potentially risking its current regulatory status and sending shares down 2%.
The company said it has 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.
Zepzelca already holds accelerated approval from the FDA as a second-line treatment, which is administered when initial treatments fail, for advanced small cell lung cancer (SCLC).
SCLC is 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.
Needham analyst Ami Fadia said the trial results put an “overhang” on approval in the second-line setting and expects to see some “temporary pressure on Zepzelca sales this year,”.
Separately, the FDA had approved Zepzelca in 2025 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.
Jazz said the trial results do not affect its 2026 outlook. Fadia said the company’s commentaries suggest no major hit to Zepzelca sales since the opportunity has now shifted to first-line maintenance setting.
Zepzelca sales rose 60% to $101 million in the first quarter, driven by continued uptake in the first-line setting, partially offset by a decline in second-line use.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar and Tasim Zahid)
