EMA Recommends Extension of Indications for Nivolumab to Include First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

On 25 April 2024, 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 nivolumab (OPDIVO).

The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted a new indication as follows:

OPDIVO in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

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

Melanoma

• OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Relative to nivolumab monotherapy, an increase in progression-free survival and overall survival for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression. 

Adjuvant treatment of melanoma

• OPDIVO as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Non-small cell lung cancer (NSCLC)

• OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic NSCLC in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
• OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults.

Neoadjuvant treatment of NSCLC

• OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%.

Malignant pleural mesothelioma

• OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

Renal cell carcinoma (RCC)

• OPDIVO as monotherapy is indicated for the treatment of advanced RCC after prior therapy in adults.
• OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced RCC.
• OPDIVO in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced RCC.

Classical Hodgkin lymphoma (cHL)

• OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory cHL after autologous stem cell transplant and treatment with brentuximab vedotin.

Squamous cell cancer of the head and neck (SCCHN)

• OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic SCCHN in adults progressing on or after platinum-based therapy.

Urothelial carcinoma

• OPDIVO in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
• OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

Adjuvant treatment of urothelial carcinoma

• OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)

• OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with dMMR or MSI-H metastatic CRC after prior fluoropyrimidine-based combination chemotherapy.

Oesophageal squamous cell carcinoma

• OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
• OPDIVO in combination with fluoropyrimidine and platinum-based combination chemotherapy is indicated for the first line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD L1 expression ≥ 1%.
• OPDIVO as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.

Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer

• OPDIVO as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.

Gastric, gastro-oesophageal junction or oesophageal adenocarcinoma

• OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score ≥ 5.

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 made 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.