Drugs

Jazz Trial Misses Survival Endpoint for Zepzelca in Lung Cancer

Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer (SCLC) failed to meet its primary endpoint of overall survival, raising questions about the future of the drug's second-line indication. The global trial, sponsored by Jazz partner PharmaMar, evaluated Zepzelca as both a monotherapy and in combination with irinotecan in patients with metastatic SCLC whose disease had progressed following platinum-based chemotherapy. Neither experimental arm demonstrated a statistically significant overall survival benefit compared with investigator's choice of topotecan or irinotecan, it says.

Median overall survival in the study's intent-to-treat population was 8.7 months for Zepzelca monotherapy, 10.9 months for the Zepzelca-irinotecan combination, and 10.7 months for the control arm, the company says. The results come nearly a year after FDA granted full approval to Zepzelca in the first-line maintenance setting based on the Phase 3 IMforte trial. Jazz emphasized that the LAGOON findings do not affect the drug's approved first-line maintenance indication.

"Relapsed SCLC is an aggressive cancer with a poor prognosis and patients continue to need treatment options, including in later lines of therapy," Jazz executive vice president Rob Iannone is quoted in a release as saying.

Despite the efficacy setback, Jazz reports a favorable safety profile relative to chemotherapy controls. Treatment-related adverse events occurred in 78.5% of patients receiving Zepzelca monotherapy compared with 93.8% in the control arm. Grade 3 or higher treatment-related adverse events were reported in 35% of patients treated with Zepzelca alone, versus 64.4% in the control group.

Zepzelca received accelerated FDA approval in 2020 for adults with metastatic SCLC whose disease progressed on or after platinum-based chemotherapy, based on tumor response and duration of response data.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome