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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).

References

  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. https://bit.ly/2LbQtG5. 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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