<p>Keytruda is a cancer medicine used to treat:</p><ul><li>melanoma, a skin cancer;</li><li>non-small cell lung cancer (NSCLC), a type of lung cancer;</li><li>non-epithelioid malignant pleural mesothelioma, a cancer of the lining of the lungs;</li><li>classical Hodgkin lymphoma, a cancer of the white blood cells;</li><li>urothelial cancer, a cancer of the bladder and urinary tract;</li><li>head and neck squamous cell carcinoma (HNSCC), a cancer affecting the head and neck;</li><li>renal cell carcinoma, a type of kidney cancer;</li><li>oesophageal cancer, a cancer of the oesophagus (gullet or food pipe);</li><li>gastric and gastro-oesophageal junction adenocarcinoma, types of cancer of the stomach and junction between the oesophagus and the stomach, respectively;</li><li>triple-negative breast cancer, a type of breast cancer;</li><li>endometrial carcinoma, a cancer of the lining of the womb;</li><li>cervical cancer, a cancer of the cervix;</li><li>biliary tract cancer, a cancer of the bile ducts (the tubes that carry bile from the liver and gallbladder to the gut or the gallbladder);</li><li>the following cancers when described as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR):<ul><li>colorectal cancer, a cancer of the colon or rectum (the lower part of the gut);</li><li>endometrial carcinoma;</li><li>gastric cancer, small intestine cancer or biliary cancer.</li></ul></li></ul><p>Keytruda is mainly used in adults for cancers that are advanced, have spread or returned, are not responding to other treatments or cannot be removed by surgery. Keytruda is also used in children aged 3 years and older with classical Hodgkin lymphoma and in adolescents aged 12 years and older with melanoma.</p><p>In some cancers, it is only given to patients whose tumours produce certain levels of a protein known as PD-L1 or are determined to be MSI-H or dMMR.</p><p>Keytruda is also used to help prevent the cancer from coming back after patients had surgery (adjuvant treatment) to remove melanoma, NSCLC or renal cell carcinoma. In some patients with triple-negative breast cancer, NSCLC or HNSCC, Keytruda can be given before (neoadjuvant treatment) and after (adjuvant treatment) surgery.</p><p>Depending on the cancer being treated, Keytruda can be used on its own or in combination with other cancer medicines such as lenvatinib, axitinib or enfortumab vedotin, chemotherapy alone or combined with the cancer medicines trastuzumab or bevacizumab, or chemotherapy combined with radiotherapy.</p><p>Keytruda contains the active substance pembrolizumab.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p><strong>Melanoma</strong></p><p style="margin-left:40px;">Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.</p><p style="margin-left:40px;">Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection.</p><p><strong>Non small cell lung carcinoma (NSCLC)</strong></p><p style="margin-left:40px;">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</p><p style="margin-left:40px;">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).</p><p style="margin-left:40px;">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.</p><p style="margin-left:40px;">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.</p><p style="margin-left:40px;">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.</p><p style="margin-left:40px;">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.</p><p><strong>Malignant pleural mesothelioma (MPM)</strong></p><p style="margin-left:40px;">Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.</p><p><strong>Classical Hodgkin lymphoma (cHL)</strong></p><p style="margin-left:40px;">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.</p><p><strong>Urothelial carcinoma</strong></p><p style="margin-left:40px;">Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy.<br><br>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.</p><p><strong>Head and neck squamous cell carcinoma (HNSCC)</strong></p><p style="margin-left:40px;">Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.</p><p style="margin-left:40px;">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.</p><p style="margin-left:40px;">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.</p><p><strong>Renal cell carcinoma (RCC)</strong></p><p style="margin-left:40px;">Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults.</p><p style="margin-left:40px;">Keytruda, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults.</p><p style="margin-left:40px;">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, please see section 5.1).</p><p><strong>Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers</strong></p><p style="margin-left:40px;"><em>Colorectal cancer (CRC)</em><br>Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings:</p><ul><li style="margin-left:40px;">first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults;</li><li style="margin-left:40px;">treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. </li></ul><p style="margin-left:40px;"><em>Non-colorectal cancers</em><br>Keytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with:</p><ul><li style="margin-left:40px;">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;</li><li style="margin-left:40px;">unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.</li></ul><p><strong>Oesophageal carcinoma</strong></p><p style="margin-left:40px;">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.</p><p><strong>Triple negative breast cancer (TNBC)</strong></p><p style="margin-left:40px;">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.</p><p style="margin-left:40px;">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.</p><p><strong>Endometrial carcinoma (EC)</strong></p><p style="margin-left:40px;">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. </p><p style="margin-left:40px;">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.</p><p><strong>Cervical cancer</strong></p><p style="margin-left:40px;">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. </p><p style="margin-left:40px;">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.</p><p><strong>Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma</strong></p><p style="margin-left:40px;">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.</p><p style="margin-left:40px;">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).</p><p><strong>Biliary tract carcinoma (BTC)</strong></p><p style="margin-left:40px;">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.</p></div>
Therapeutic Area (MeSH)
ATC Code
L01FF02
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| pembrolizumab | N/A | pembrolizumab |
EMA Name
Keytruda
Medicine Name
Keytruda
Aliases
N/ANo risk management plan link.
