FDA News

FDA grants priority review to lurbinectedin for relapsed small cell lung cancer

The FDA granted priority review to lurbinectedin for the treatment of small cell lung cancer that relapsed after platinum-based therapy, according to a press release from the agent’s manufacturer.

Lurbinectedin (PM1183; PharmaMar, Jazz Pharmaceuticals) is an investigational RNA polymerase II inhibitor. The RNA polymerase II enzyme is essential for the transcription process and is overactivated in tumors with transcription addiction.

The manufacturer submitted the new drug application for lurbinectedin based on results of a phase 2 monotherapy basket trial, results of which were presented at last year’s ASCO Annual Meeting and previously reported by Healio.

The trial included 105 patients (median age, 60 years; 60% men) with relapsed small cell lung cancer who received 3.2 mg/m² lurbinectedin IV every 3 weeks.

The trial met its primary endpoint of objective response rate, with an ORR 35.2% (95% CI, 26.2-45.2) among all patients, 45% (95% CI, 32.1-58.4) among those with sensitive disease and 22.2% (95% CI, 11.2-37.1) among those with resistant disease.

Median PFS was 3.9 months (95% CI, 2.6-4.6) among all patients, 4.6 months (95% CI, 3-6.5) among those with sensitive disease, and 2.6 months (95% CI, 1.3-3.9) among those with resistant disease. Median OS was 9.3 months (95% CI, 6.3-11.8) for all patients, 11.9 months (95% CI, 9.7-16.2) for those with sensitive disease, and 5 months (95% CI, 4.1-6.3) for those with resistant disease.

The FDA previously granted lurbinectedin orphan drug status for the treatment of small cell lung cancer. The last new agent approved for relapsed small cell lung cancer was topotecan, more than 2 decades ago.

The FDA set a target action date for this application of Aug. 16.

 

 

The FDA granted priority review to lurbinectedin for the treatment of small cell lung cancer that relapsed after platinum-based therapy, according to a press release from the agent’s manufacturer.

Lurbinectedin (PM1183; PharmaMar, Jazz Pharmaceuticals) is an investigational RNA polymerase II inhibitor. The RNA polymerase II enzyme is essential for the transcription process and is overactivated in tumors with transcription addiction.

The manufacturer submitted the new drug application for lurbinectedin based on results of a phase 2 monotherapy basket trial, results of which were presented at last year’s ASCO Annual Meeting and previously reported by Healio.

The trial included 105 patients (median age, 60 years; 60% men) with relapsed small cell lung cancer who received 3.2 mg/m² lurbinectedin IV every 3 weeks.

The trial met its primary endpoint of objective response rate, with an ORR 35.2% (95% CI, 26.2-45.2) among all patients, 45% (95% CI, 32.1-58.4) among those with sensitive disease and 22.2% (95% CI, 11.2-37.1) among those with resistant disease.

Median PFS was 3.9 months (95% CI, 2.6-4.6) among all patients, 4.6 months (95% CI, 3-6.5) among those with sensitive disease, and 2.6 months (95% CI, 1.3-3.9) among those with resistant disease. Median OS was 9.3 months (95% CI, 6.3-11.8) for all patients, 11.9 months (95% CI, 9.7-16.2) for those with sensitive disease, and 5 months (95% CI, 4.1-6.3) for those with resistant disease.

The FDA previously granted lurbinectedin orphan drug status for the treatment of small cell lung cancer. The last new agent approved for relapsed small cell lung cancer was topotecan, more than 2 decades ago.

The FDA set a target action date for this application of Aug. 16.