Keytruda’s 25th EU green light

Today’s approval by the European commission of Keytruda monotherapy for adjuvant NSCLC marks the Merck & Co drug’s 25th green light in the EU. It is backed by the Keynote-091 (Pearls) study, and comes after a 15 September positive CHMP recommendation. On Friday the CHMP recommended approving Keytruda plus chemo for HER2-negative, ≥1% PD-L1-expressing gastric/GEJ adenocarcinoma; that indication, backed by Keynote-859, is also under review in the US, where Merck appears to be pursuing an all-comers label. Keytruda's EU approvalsApproval dateRegimenIndicationSupporting trials(s)16 Oct 2023MonotherapyAdjuvant stage IB-IIIA NSCLCKeynote-091 (Pearls)29 Aug 2023Herceptin+chemo combo1st-line Her2 +ve PD-L1 +ve (≥1%) gastric/GEJ adenocarcinomaKeynote-81124 Jun 2022MonotherapyAdjuvant stage IIB/C melanomaKeynote-71624 May 2022Chemo+monotherapyNeoadjuvant + adjuvant triple-negative breast cancerKeynote-52229 Apr 2022Chemo +/- Avastin combo1st-line PD-L1 +ve (≥1%) cervical cancerKeynote-82629 Apr 2022Monotherapy2nd-line MSI-H/dMMR colorectal, endometrial, gastric, small intestine or biliary cancersKeynote-164 & 15828 Jan 2022MonotherapyAdjuvant renal cell carcinomaKeynote-56429 Nov 2021Lenvima combo1st-line renal cell carcinomaKeynote-581 (Clear)29 Nov 2021Lenvima combo2nd-line endometrial carcinomaKeynote-77522 Oct 2021Chemo combo1st-line PD-L1 +ve (≥10%) triple-negative breast cancerKeynote-35529 Jun 2021Chemo combo1st-line PD-L1 +ve (≥10%) Her2 -ve oesophageal/GEJ carcinomaKeynote-59026 Jan 2021Monotherapy1st-line MSI-H or mismatch repair-deficient colorectal cancerKeynote-17717 Mar 2021MonotherapyASCT-relapsed or 3rd-line classical Hodgkin lymphomaKeynote-20426 Jan 2021Monotherapy1st-line MSI-H or mismatch repair-deficient colorectal cancerKeynote-17720 Nov 2019Monotherapy1st-line PD-L1 +ve (≥1%) head & neck cancerKeynote-04820 Nov 2019Chemo combo1st-line PD-L1 +ve (≥1%) head & neck cancerKeynote-0484 Sep 2019Inlyta combo1st-line renal cell carcinomaKeynote-42614 Mar 2019Chemo combo1st-line squam NSCLCKeynote-40717 Dec 2018MonotherapyAdjuvant melanomaKeynote-05410 Sep 2018Chemo combo1st-line Alk & EGFR -ve non-squam NSCLCKeynote-1895 Sep 2017Monotherapy2nd-line or chemo-ineligible (1st-line) urothelial carcinomaKeynote-045 & 0525 May 2017Monotherapy3rd-line classical Hodgkin lymphomaKeynote-087 & 01316 Dec 2016Monotherapy1st-line PD-L1 +ve (≥50%), Alk & EGFR -ve, NSCLCKeynote-0242 Aug 2016Monotherapy2nd-line PD-L1 +ve (≥50%) NSCLCKeynote-01022 Jul 2015Monotherapy1st & 2nd-line melanoma regardless of Braf statusKeynote-001, 002 & 006Source: OncologyPipeline.