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FDA Issues Complete Response Letter for Updated Pembrolizumab Dosing Schedule

Gina Columbus @ginacolumbusonc
Published: Wednesday, Feb 19, 2020

The FDA has issued a complete response letter (CRL) to 6 supplemental biologics license applications (sBLAs) that would have updated the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions across multiple indications.1

For the sBLAs, the dosing schedule would have been updated in the following indications:
  • Patients with unresectable or metastatic melanoma;
  • Adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection;
  • For the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma;
  • Adult and pediatric patients with refractory classical Hodgkin lymphoma, or who have relapsed after 3 or more prior lines of therapy;
  • Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed following ≥2 lines of prior therapy;
  • Patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1);
  • Patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).
In March 2019, the European Commission approved the 400-mg every-6-week dosing schedule in all of pembrolizumab’s single-agent indications, which also include non–small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, microsatellite instability–high or mismatch repair deficient solid tumors, and cervical cancer.

References

  1. Merck receives complete response letter from the US FDA for supplemental biologics license applications (sBLAs) for Keytruda (pembrolizumab) six-week dosing schedule [news release]: Kenilworth, NJ. Merck. Published February 18, 2020. https://bit.ly/2HzEn5Y. Accessed February 18, 2020.
  2. Lala M, Li M, Sinha V, de Alwis D, Chartash E, Jain L. A six-weekly (Q6W) dosing schedule for pembrolizumab based on an exposure-response (E-R) evaluation using modeling and simulation. J Clin Oncol. 2018;36 (suppl; abstr 306). doi: 10.1200/JCO.2018.36.15_suppl.3062.

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