Keytruda - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation.
pembrolizumab
Post-authorisationHuman
On 27 February 2025, the Committee for Medicinal Products for Human Use (CHMP), following a re-examination procedure, adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Keytruda. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
The CHMP adopted a new indication as follows:
Malignant pleural mesothelioma (MPM)
Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
For information, the full indications for Keytruda will be as follows:1
Melanoma
Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.
Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1).
Non‑small cell lung carcinoma (NSCLC)
Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non‑small cell lung carcinoma at high risk of recurrence in adults (for selection criteria, see section 5.1).
Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy (for selection criteria, see section 5.1).
Keytruda as monotherapy is indicated for the first‑line treatment of metastatic non‑small cell lung carcinoma in adults whose tumours express PD‑L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non‑squamous non‑small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.
Keytruda, in combination with carboplatin and either paclitaxel or nab‑paclitaxel, is indicated for the first‑line treatment of metastatic squamous non‑small cell lung carcinoma in adults.
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic non‑small cell lung carcinoma in adults whose tumours express PD‑L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
Malignant pleural mesothelioma (MPM)
Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
Classical Hodgkin lymphoma (cHL)
Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
Urothelial carcinoma
Keytruda, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum‑containing chemotherapy (see section 5.1).
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin‑containing chemotherapy and whose tumours express PD‑L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Head and neck squamous cell carcinoma (HNSCC)
Keytruda, as monotherapy or in combination with platinum and 5‑fluorouracil (5‑FU) chemotherapy, is indicated for the first‑line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 (see section 5.1).
Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD‑L1 with a ≥ 50% TPS and progressing on or after platinum‑containing chemotherapy (see section 5.1).
Renal cell carcinoma (RCC)
Keytruda, in combination with axitinib, is indicated for the first‑line treatment of advanced renal cell carcinoma in adults (see section 5.1).
Keytruda, in combination with lenvatinib, is indicated for the first‑line treatment of advanced renal cell carcinoma in adults (see section 5.1).
Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, see section 5.1).
Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers
Colorectal cancer (CRC)
Keytruda as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings:
- first‑line treatment of metastatic colorectal cancer;
treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy.
Non-colorectal cancers
Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with:
- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation;
- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Oesophageal carcinoma
Keytruda, in combination with platinum and fluoropyrimidine‑based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD‑L1 with a CPS ≥ 10 (see section 5.1).
Triple‑negative breast cancer (TNBC)
Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence (see section 5.1).
Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple‑negative breast cancer in adults whose tumours express PD‑L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).
Endometrial carcinoma (EC)
Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.
Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation.
Cervical cancer
Keytruda, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.
Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥ 1.
Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma
Keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 (see section 5.1).
Biliary tract carcinoma (BTC)
Keytruda, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold
CHMP post-authorisation summary of positive opinion for Keytruda
AdoptedReference Number: EMA/60149/2025
English (EN) (198.4 KB - PDF)
First published: