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FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

Gina Columbus @ginacolumbusonc
Published: Tuesday, Jul 09, 2019

The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.1 The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and primary mediastinal large B-cell lymphoma.

For the sBLAs, the dosing schedule would be 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).


  1. FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications. Merck. Published July 9, 2019. Accessed July 9, 2019.
  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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