← All approvals · Cancer · 2025
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
The FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) on September 19, 2025 to treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.
- Brand name
- Keytruda Qlex
- Generic name
- pembrolizumab and berahyaluronidase alfa-pmph
- FDA approval date
- September 19, 2025
- Approved use (FDA wording)
- To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab
- Company
- Merck Sharp Dohme
- Application
- BLA761467
- Dosage form / route
- INJECTABLE · INJECTION
- Drug class (EPC)
- Endoglycosidase [EPC]
- Boxed warning on label
- Not listed
- Category on this site
- Cancer
Indications and usage, from the FDA label
KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclit…