On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved a new administration method for Keytruda (pembrolizumab). Under the new approval, Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) can now be given by subcutaneous injection, commonly known as a shot, in addition to the usual administration method of infusion into the bloodstream (intravenous/IV).  

Keytruda (pembrolizumab) is already approved for use in several cancers, including non-small cell lung cancer (NSCLC). Until now, it was administered through an IV into the bloodstream, which typically took about 30 minutes. With this new approval, patients can receive the medication as a shot in about 5 minutes—improving treatment time and convenience. The added ingredient, berahyaluronidase alfa-pmph, helps improve the absorption and dispersion of Keytruda (pembrolizumab) within the body.  

This approval includes all the same solid tumor uses of Keytruda (pembrolizumab) that the FDA previously approved for adults and children 12 years and older, including for use as a standalone therapy or in combination with other treatments for NSCLC. 

This latest approval is based on the results of the MK-3475A-D77 study, which compared the use of Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) given by a shot under the skin along with chemotherapy versus Keytruda (pembrolizumab), which is given as an infusion along with chemotherapy. The study showed no notable differences in the drug’s safety profile between the 2 administration methods.  

Please speak with your healthcare team for more information about Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) to see if it may be a good option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.   

Read the full FDA announcement.