What to Know About Keytruda's 'Under-the-Skin' Option
- The U.S. Food and Drug Administration (FDA) has approved the subcutaneous form of Keytruda for a new ‘Under-the-Skin’ Option for patients. The subcutaneous form of Keytruda showed to deliver the same benefits as the regular IV infusion, with no meaningful differences in outcomes or safety.
- This approval means patients with solid tumors can receive Keytruda as a quick injection under the skin, instead of through a traditional intravenous (IV) infusion.
- Dr. Sonam Puri, a Thoracic Medical oncologist, says, “What really changes for patients is the time commitment. With IV therapy, you’re planning a multi-hour visit to the infusion center—pre-medications, drug preparation, and sitting in a chair with an IV. With the injection, patients can be in and out much faster.
- For those receiving immunotherapy alone, the injection can significantly reduce time spent in the clinic compared with long visits.
- Keytruda’s main competition in this pharmaceutical space is nivolumab (brand name: Opdivo), which received FDA approval in December 2024. Currently, Keytruda has 41 indications across more than 18 cancer types, according to the FDA.
Pembrolizumab is already a cornerstone treatment for many cancers, including lung, bladder, melanoma, and several other solid tumors. This treatment type is an immunotherapy that has emerged as a transformative force in oncology. Rather than attacking cancer cells directly, it empowers the body’s own immune system to do the work.
Read MorePatient Perspective: What Are the Benefits of This Approval?
Dr. Sonam Puri, a Thoracic Medical oncologist and a Research Medical Director at the Moffitt Cancer Center, in Tampa, Florida, shares with SurvivorNet: “What really changes for patients is the time commitment. With IV therapy, you’re planning a multi-hour visit to the infusion center—pre-medications, drug preparation, and sitting in a chair with an IV. With the injection, patients can be in and out much faster. For someone receiving only immunotherapy, that’s a very meaningful change.”For many people, this change could make cancer treatment more convenient and less disruptive. The new injection takes only minutes to administer, compared to the longer appointments needed for IV infusions. This could mean less time spent in clinics, shorter waits, and fewer hours in a treatment chair. Patients who live far from infusion centers, have limited mobility, or simply want to reduce the burden of treatment may find this option particularly valuable.
“There are costs attached to IV treatment—infusion center time, the need for a port, and staffing. The subcutaneous form could help reduce some of those burdens,” Dr. Puri adds.
A large clinical trial in patients with non-small cell lung cancer provided support for the FDA approval.
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The study showed that the under-the-skin injection worked just as well as the IV form. Treatment response rates and survival outcomes were nearly identical between the two groups, and the side effects were consistent as well. The most common difference was mild reactions at the injection site, such as redness or swelling, which were generally manageable.
Dr. Puri also adds that “If patients are also receiving IV chemotherapy, the benefit is less clear. They’ll still need to go to the infusion center, so switching Keytruda to an injection doesn’t reduce much of their time.”
Overall, she says that “there are patients with skin conditions or sensitivities that could make injections every few weeks difficult, but overall the safety profile looks very similar.”
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A Step Toward Patient-Friendly Cancer Care
This approval highlights a growing trend in oncology: making cancer treatment not only effective, but also easier and less burdensome for patients.
Pembrolizumab has already changed the landscape of cancer therapy by harnessing the body’s immune system to fight tumors. Now, with a simpler and quicker method of delivery, patients may gain more flexibility and comfort as they continue treatment.
“I do think this will impact how health systems manage care. Right now, every treatment visit involves labs, clearance, and an in-person check-in. In the future, I could see some of those visits being replaced with virtual check-ins. How this plays out in real-world practice—both for patients and for the healthcare system—is the next chapter,” Dr. Puri emphasizes.
While the subcutaneous version may not be the right choice for everyone—such as those who still need regular IV medications—it represents an important step toward improving quality of life during cancer treatment.
What to ask your doctor
If you are receiving pembrolizumab or are about to start treatment, it’s worth asking your doctor whether the new subcutaneous form might be right for you. Key questions include:
- Am I eligible for the injection version of pembrolizumab for my type of cancer?
- How often would I need to come in—every three weeks or every six weeks—and which schedule makes the most sense for me?
- Will the injection be available at my treatment center, and will my insurance cover it?
- What are the possible side effects of the injection, and how do they compare with the infusion?
- If I am receiving other IV medications, would switching to the injection actually save time?
Your doctor can help you understand whether the new formulation will genuinely change your treatment routine and what it might mean for your overall care plan.
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