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 approvals
| Approval date | Regimen | Indication | Supporting trials(s) |
|---|---|---|---|
| 16 Oct 2023 | Monotherapy | Adjuvant stage IB-IIIA NSCLC | Keynote-091 (Pearls) |
| 29 Aug 2023 | Herceptin+chemo combo | 1st-line Her2 +ve PD-L1 +ve (≥1%) gastric/GEJ adenocarcinoma | Keynote-811 |
| 24 Jun 2022 | Monotherapy | Adjuvant stage IIB/C melanoma | Keynote-716 |
| 24 May 2022 | Chemo+monotherapy | Neoadjuvant + adjuvant triple-negative breast cancer | Keynote-522 |
| 29 Apr 2022 | Chemo +/- Avastin combo | 1st-line PD-L1 +ve (≥1%) cervical cancer | Keynote-826 |
| 29 Apr 2022 | Monotherapy | 2nd-line MSI-H/dMMR colorectal, endometrial, gastric, small intestine or biliary cancers | Keynote-164 & 158 |
| 28 Jan 2022 | Monotherapy | Adjuvant renal cell carcinoma | Keynote-564 |
| 29 Nov 2021 | Lenvima combo | 1st-line renal cell carcinoma | Keynote-581 (Clear) |
| 29 Nov 2021 | Lenvima combo | 2nd-line endometrial carcinoma | Keynote-775 |
| 22 Oct 2021 | Chemo combo | 1st-line PD-L1 +ve (≥10%) triple-negative breast cancer | Keynote-355 |
| 29 Jun 2021 | Chemo combo | 1st-line PD-L1 +ve (≥10%) Her2 -ve oesophageal/GEJ carcinoma | Keynote-590 |
| 26 Jan 2021 | Monotherapy | 1st-line MSI-H or mismatch repair-deficient colorectal cancer | Keynote-177 |
| 17 Mar 2021 | Monotherapy | ASCT-relapsed or 3rd-line classical Hodgkin lymphoma | Keynote-204 |
| 26 Jan 2021 | Monotherapy | 1st-line MSI-H or mismatch repair-deficient colorectal cancer | Keynote-177 |
| 20 Nov 2019 | Monotherapy | 1st-line PD-L1 +ve (≥1%) head & neck cancer | Keynote-048 |
| 20 Nov 2019 | Chemo combo | 1st-line PD-L1 +ve (≥1%) head & neck cancer | Keynote-048 |
| 4 Sep 2019 | Inlyta combo | 1st-line renal cell carcinoma | Keynote-426 |
| 14 Mar 2019 | Chemo combo | 1st-line squam NSCLC | Keynote-407 |
| 17 Dec 2018 | Monotherapy | Adjuvant melanoma | Keynote-054 |
| 10 Sep 2018 | Chemo combo | 1st-line Alk & EGFR -ve non-squam NSCLC | Keynote-189 |
| 5 Sep 2017 | Monotherapy | 2nd-line or chemo-ineligible (1st-line) urothelial carcinoma | Keynote-045 & 052 |
| 5 May 2017 | Monotherapy | 3rd-line classical Hodgkin lymphoma | Keynote-087 & 013 |
| 16 Dec 2016 | Monotherapy | 1st-line PD-L1 +ve (≥50%), Alk & EGFR -ve, NSCLC | Keynote-024 |
| 2 Aug 2016 | Monotherapy | 2nd-line PD-L1 +ve (≥50%) NSCLC | Keynote-010 |
| 22 Jul 2015 | Monotherapy | 1st & 2nd-line melanoma regardless of Braf status | Keynote-001, 002 & 006 |
Source: OncologyPipeline.
