The U.S. Food and Drug Administration (FDA) has approved a new injectable version of pembrolizumab called Keytruda Qlex for certain types of non-small cell lung cancer (NSCLC). 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 it’s given under the skin

Based on clinical trials, these medicines 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 dosing.

What Types of Lung Cancer Is It Approved For?

This new injection formulation is approved for nearly all the same uses as IV Keytruda. For NSCLC, this includes:

• First-line treatment with chemotherapy — For people with metastatic nonsquamous NSCLC (without EGFR or ALK tumor changes) in combination with pemetrexed and platinum chemotherapy or for metastatic (advanced) squamous NSCLC in combination with carboplatin and paclitaxel
• First-line treatment as a single drug — For people whose tumors express PD-L1 and who don’t have EGFR or ALK changes
• Second-line treatment as a single drug — For people with advanced NSCLC whose tumors express PD-L1 and whose disease worsened after chemotherapy
• Treatment before and after surgery — For people with resectable NSCLC, along with chemotherapy before surgery and continued as a single drug after surgery
• Adjuvant treatment after surgery — For people with stage 1B, 2, or 3A NSCLC following surgery and platinum-based chemotherapy

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, and overall survival, were nearly identical. Safety results were also similar.

This means that for people with lung cancer 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
• Hypothyroidism

When the immune system attacks healthy organs, it can lead to 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. It can also cause harm to an unborn baby when taken during pregnancy.

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

Why This Matters for People With Lung 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, giving people a new option without compromising safety or effectiveness.

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

Learn more about treatment options for lung cancer.

Join the Conversation

On MyLungCancerTeam, people share their experiences with lung 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.