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FDA Grants Priority Review to Durvalumab for Locally Advanced Unresectable NSCLC

Jason Harris
Published: Tuesday, Oct 17, 2017

lung cancer
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with stage III, unresectable non–small cell lung cancer (NSCLC), based on positive progression-free survival (PFS) results from the PACIFIC trial.

Three studies exploring durvalumab in multiple myeloma—MEDI4736-MM-001, MEDI4736-MM-003, and MEDI4736-MM-005—were placed on partial hold. MEDI4736-NHL-001, exploring the drug as a monotherapy in patients with lymphoma or chronic lymphocytic leukemia, and MEDI4736-DLBCL-001, assessing durvalumab in combination with R-CHOP or R2 CHOP, where also given a partial hold. Patients deriving clinical benefit from treatment, as determined by the investigator, can remain on treatment in these 5 studies, but enrollment has stopped for the time being.

References

  1. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage iii non–small-cell lung cancer. N Engl J Med. doi: 10.1056/NEJMoa1709937.
  2. FDA Alerts Healthcare Professionals and Oncology Clinical Investigators about Two Clinical Trials on Hold Evaluating KEYTRUDA® (pembrolizumab) in Patients with Multiple Myeloma. https://www.fda.gov/Drugs/DrugSafety/ucm574305.htm. Accessed August 31, 2017.

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Online CME Activities
TitleExpiration DateCME Credits
Advances in™ Therapies for Patients With ALK-Positive Lung Cancers: More Options…More Decisions…Better OutcomesAug 30, 20191.5
Oncology Briefings™: Treating Advanced NSCLC Without Actionable MutationsAug 30, 20191.0
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