Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev ® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
This approval, which also covers KEYTRUDA SC ® [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU.
These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2α inhibitor combination regimens.
This approval, which also covers KEYTRUDA SC ® [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this regimen the first and only PD-1 inhibitor-based treatment option for eligible patients with platinum-resistant ovarian cancer in the EU.
Based on these data, the U.S. FDA has accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX™ for the adjuvant treatment of certain patients with RCC
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens.
KEYTRUDA SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], is a subcutaneous injection containing pembrolizumab and berahyaluronidase alfa and has been approved for use across all 33 KEYTRUDA indications for adult patients in Europe.
ChEMBL registry synonym — accepted as the source's own labelCHEMBL5314725 ↗
Known as
Berahyaluronidasa alfa
ChEMBL registry synonym — accepted as the source's own labelCHEMBL5314725 ↗
Known as
hyaluronidase PH20
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT05756595 ↗
Modality
Protein / enzyme biologic
“the investigators, recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20 or SPAM1) of bovine testicular sperm acrosome were used to cleave macromolecular Hyaluronan.” NCT05756595 ↗
Route
Subcutaneous
“Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.” NCT05017012 ↗