FDA approves subcutaneous injection of Keytruda

Hyaluronidase alpha-pmph is a form of human hyaluronidase developed by Alteogen. Merck announced that it plans to launch Keytruda QLEX at the end of September. The drug is the first immune checkpoint inhibitor administered subcutaneously in the United States.

The subcutaneous injection is administered over one minute every three weeks or two minutes every six weeks. The company noted that this injection provides faster delivery than the intravenous version of pembrolizumab (which requires a 30-minute administration). Furthermore, the new formulation will allow for a wider range of healthcare facilities to administer the treatment.

The FDA approval is based on an Merck trial comparing the efficacy of subcutaneous Keytruda QLEX with intravenous Keytruda every six weeks in combination with chemotherapy. Participants included 377 patients with previously untreated metastatic non-small cell lung cancer.

The study demonstrated comparable pharmacokinetic exposure levels of pembrolizumab across the different formulations, with similar response rates and no significant differences in progression-free survival or overall survival.

Keytruda has been approved for use in Russia since 2016. In 2018, pembrolizumab was included in the list of vital and essential drugs, and since 2020, it has been included in the list of strategically important drugs, the production of which must be ensured in Russia.

Currently, three drugs containing the active ingredient pembrolizumab are registered in Russia: the original Keytruda from MSD, Arflaida from R-Pharm, and Pembrolizumab from Biocad's PC-137 manufacturing complex. The latter drug was registered in December 2022, becoming the first Russian biosimilar to the original Keytruda.

By the end of the first quarter of 2023, generic purchases accounted for over 80% of purchases under this INN. Arfleyda from R-Pharm was registered in February 2024. The maximum selling price of the original Keytruda is 155,000 rubles, the generic from Biocad is 108,500 rubles, and Arfleyda is 88,000 rubles.

In January 2025, the Supreme Court of the Russian Federation settled the case against Nizhny Novgorod Regional Pharmacy. The state pharmacy had appealed the decision of the Moscow District Arbitration Court, which ruled that in its 2023 procurement, the company had improperly specified the specific product name and manufacturer of the anticancer drug containing pembrolizumab—Microsoft's Keytruda. More details on the dispute can be found in Vademecum's article .