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.
- 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.
- 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.
... to read the full story