FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcuta

The FDA recently approved the combination of the cancer drug pembrolizumab with berahyaluronidase alfa-pmph (branded as KEYTRUDA Qlex) for subcutaneous (under the skin) injection in adults and pediatric patients (12 years and older) with solid tumors, offering a faster and more convenient administration than the traditional intravenous route. This approval is for the same indications that pembrolizumab (KEYTRUDA) was already approved for, but now allows for a significantly reduced injection time, from minutes in the treatment room to a few minutes under the skin.

How it works
Pembrolizumab: A type of immunotherapy that blocks the PD-1 pathway, allowing the patient's immune system to detect and fight cancer cells.
Berahyaluronidase alfa-pmph: An enzyme that temporarily breaks down hyaluronic acid in the skin, creating space for the pembrolizumab to be absorbed more quickly and effectively.

Key Benefits
- Speed: Significantly shortens the time required for administration.
- Convenience: Offers a more patient-friendly way to receive treatment.
- Non-Inferior Efficacy: Clinical trials demonstrated that the subcutaneous formulation was non-inferior to the intravenous formulation in terms of its effectiveness.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection