Newsflash
Prodotti competitors / Area Oncology

CHMP positive opinion for pembrolizumab (KEYTRUDA) as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma (NSCLC)

  • 18 settembre 2023 - Newsletter n. 40 - Settembre 2023
Immagine News
Attenzione! Il presente contenuto è disponibile solo in lingua originale.

On 14 September 2023, the 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 Keytruda.

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

The CHMP adopted a new indication for the treatment of non-small cell lung carcinoma. 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 (see section 5.1).

Non‑small cell lung carcinoma (NSCLC)

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.

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 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 or HER-2 negative gastroesophageal junction adenocarcinoma, 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 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 gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.

Tags:
Grazie per il tuo feedback!