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FDA Grants Priority Review to Lurbinectedin in Small Cell Lung Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Feb 17, 2020

The FDA has granted a priority review designation to a new drug application (NDA) for lurbinectedin as a treatment for patients with small cell lung cancer (SCLC) who have progressed following platinum-containing therapy.1

The most common grade 1/2 AEs included fatigue (51.4%), nausea (32.4%), decreased appetite (21.0%), vomiting (18.1%), diarrhea (12.4%), constipation (9.5%), and neutropenia (5.7%). Grade 3/4 AEs included neutropenia (22.9%), anemia (6.7%), fatigue (6.7%), thrombocytopenia (4.8%), febrile neutropenia (4.8%), pneumonia (1.9%), increased alanine aminotransferase level (1.9%), skin ulcer (1.0%), and diarrhea (1.0%).

References

  1. PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer [news release]: Madrid, Spain and Dublin, Ireland. PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc. Published February 17, 2020. https://prn.to/2SAMHsv. Accessed February 17, 2020.
  2. Paz-Ares LG, Perez JMT, Besse B, et al. Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial. J Clin Oncol. 2019;37(suppl; abstr 8506). doi: 10.1200/JCO.2019.37.15_suppl.8506.

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