Merck’s (MRK) Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a novel formulation of the popular cancer medication Keytruda that may be injected subcutaneously, has received U.S. FDA approval. The clearance represents a major breakthrough in cancer treatment, providing patients with a variety of solid tumors with a quicker and easier option.
The first and only immune checkpoint inhibitor to be delivered subcutaneously is Keytruda Qlex. Berahyaluronidase alfa, an enzyme that helps the medicine dissolve and be absorbed when injected beneath the skin, is combined with pembrolizumab, an anti-PD-1 treatment, in the novel formulation. This enables a significantly shorter administration time as little as one minute than the 30-minute intravenous infusion needed for Keytruda’s original formulation.
Most adult solid tumor indications now available for intravenous Keytruda are covered by the FDA’s clearance, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and urothelial cancer, among others. The findings of the Study 3475A-D77 clinical trial, which showed that Keytruda Qlex had an equivalent safety and efficacy profile to intravenous Keytruda, served as the basis for the approval.
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This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers. We now have a new option with a broad set of indications that has demonstrated comparability with intravenous (IV) pembrolizumab but in a subcutaneous injection that can be administered in one minute every three weeks or two minutes every six weeks,
Subcutaneous pembrolizumab provides faster administration than IV pembrolizumab, offers two dosing options and gives patients more choices of health care settings in which they can receive their therapy.
Dr. J. Thaddeus Beck
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Keytruda Qlex is approved for most solid tumor indications for which adult intravenous Keytruda is approved. This covers a wide variety of cancers, including:
- Melanoma: For the treatment of metastatic or incurable melanoma, as well as as a post-complete resection adjuvant for Stage IIB, IIC, or III melanoma.
- Non-Small Cell Lung Cancer (NSCLC): For different stages and varieties of NSCLC, in different combinations and as a single agent.
- Head and Neck Squamous Cell Carcinoma (HNSCC): For recurring, metastatic, or incurable head and neck squamous cell carcinoma.
- Urothelial Cancer: When treating locally progressed or metastatic urothelial carcinoma, enfortumab vedotin is used in conjunction with it.
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A medical professional will inject Keytruda Qlex subcutaneously into the belly or thigh. With choices for a one-minute injection every three weeks or a two-minute injection every six weeks, the dosing regimen is likewise adjustable. The clinical investigation found that musculoskeletal pain, weariness, and nausea were the most often reported adverse responses.
With a less intrusive injection route and a shorter hospital stay, this novel subcutaneous formulation is anticipated to enhance the treatment experience for many cancer patients.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
