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.
- 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.
- 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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