On 9 November 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product pembrolizumab (Keytruda).

The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted a new indication as follows:

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.

For information, the full indications for Keytruda will be as follows (new indication in bold):

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. 

Non-small cell lung carcinoma (NSCLC)

  • KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with NSCLC who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
  • KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK tumour mutations.
  • KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK mutations.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
  • KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC 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 tumour mutations should also have received targeted therapy before receiving KEYTRUDA. 

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 cHL 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 as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
  • 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.

Head and neck squamous cell carcinoma (HNSCC)

  • KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent HNSCC in adults whose tumours express PD-L1 with a CPS ≥ 1.
  • KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. 

Renal cell carcinoma (RCC)

  • KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced RCC in adults.
  • KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced RCC in adults.
  • KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

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 CRC in the following settings:

  • first-line treatment of metastatic CRC;
  • treatment of unresectable or metastatic CRC 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. 

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 TNBC at high risk of recurrence.
  • KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic TNBC in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. 

Endometrial carcinoma (EC)

  • 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 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 GEJ 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 GEJ adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. 

Biliary tract carcinoma

  • 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, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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