The U.S. Food and Drug Administration (FDA) has approved a new injectable version of pembrolizumab called Keytruda Qlex for melanoma. 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 Melanoma Is It Approved For?

This formulation is approved for most of the same uses as the IV version. For melanoma, this includes:

• Unresectable or metastatic melanoma — Used in adults when the cancer has spread or cannot be surgically removed
• Adjuvant treatment — Given to adults and adolescents aged 12 years and older after surgery for stage 2B, 2C, or 3 melanoma to help prevent recurrence

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 melanoma 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, this 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. Severe 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 Melanoma

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 melanoma and curious about new treatment options, talk with your healthcare provider. Together, you can decide on a melanoma therapy plan that supports your treatment goals.

Learn more about treatment options for melanoma.

Join the Conversation

On MyMelanomaTeam, people share their experiences with melanoma, 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.