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Keytruda in 60 Seconds: FDA Approves Injection for Endometrial Cancer

Written by Ted Samson
Posted on October 8, 2025

The U.S. Food and Drug Administration (FDA) has approved a new injectable version of pembrolizumab called Keytruda Qlex for advanced and recurrent endometrial cancer. This formulation can be given as a quick, one- to two-minute subcutaneous (under the skin) injection — much shorter than the 30-minute intravenous (IV) infusion required for standard pembrolizumab (Keytruda).

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What Is Keytruda Qlex?

A type of immunotherapy, Keytruda Qlex combines two medicines:

  • Pembrolizumab — An immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells by blocking a protein called PD-1
  • Berahyaluronidase alfa-pmph — An enzyme that helps the body absorb pembrolizumab when given under the skin

In clinical trials, these medicines appear to work together in the same way as IV pembrolizumab.

Keytruda Qlex is given under the skin in the thigh or abdomen by a healthcare provider once every three or six weeks, depending on the dosing schedule.

What Types of Endometrial Cancer Is It Approved For?

This injectable version is approved for most of the same uses as the IV formulation. For endometrial cancer, it can be used:

  • In combination with chemotherapy (carboplatin and paclitaxel), followed by Keytruda Qlex alone, for people with primary advanced or recurrent endometrial cancer
  • With lenvatinib, for advanced endometrial cancer that is not microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR), after previous systemic treatment
  • Alone, for MSI-H or dMMR endometrial cancer after prior systemic treatment in people who are not eligible for surgery or radiation

How Does It Compare to IV Pembrolizumab?

In a large clinical trial of people with lung cancer, the subcutaneous injection was shown to be just as effective as the IV version. Key outcomes, such as response rates, progression-free survival (time before the cancer grows or spreads), and overall survival, were nearly identical. Safety results were also similar.

This means that for people with endometrial and other cancers, pembrolizumab delivered via an injection appears to be as effective as the IV version.

What Are the Side Effects?

The most common side effects include:

  • Fatigue
  • Musculoskeletal pain
  • Rash
  • Diarrhea
  • Fever
  • Cough
  • Decreased appetite
  • Itching
  • Shortness of breath
  • Constipation
  • Abdominal pain
  • Nausea
  • Underactive thyroid

When the immune system attacks healthy organs, it can lead to rare but serious side effects. These include lung inflammation, bowel inflammation, liver problems, hormone gland issues, kidney inflammation, and severe skin reactions. Serious allergic reactions and complications after a bone marrow transplant are also possible. The medication can also harm the fetus when taken during pregnancy.

Other side effects may occur when pembrolizumab is taken alongside other treatments.

Why This Matters for People With Endometrial Cancer

The new injection format may make cancer treatment faster and more convenient for many people. Unlike IV infusions, subcutaneous injections don’t require a port or lengthy visits to an infusion center. Instead, treatment can take as little as a minute or two at a local clinic or doctor’s office.

Notably, studies show that the injectable version works just as well as the IV version, which gives people a new option without compromising safety or effectiveness.

If you’re living with endometrial cancer and curious about new treatment options, talk with your healthcare provider. Together, you can decide on a therapy plan that supports your treatment goals.

Learn more about treatment options for endometrial cancer.

Join the Conversation

On MyEndometrialCancerTeam, people share their experiences with endometrial cancer, get advice, and find support from others who understand.

Would you prefer an injection over an infusion for your treatment? Let others know in the comments below.

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