Recently, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the marketing authorization terms of the anticancer drug Nivolumab (Opdivo).
Details of the new indication
The new indication adopted by the CHMP is as follows:
Nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (AVD) is indicated for the treatment of previously untreated stage III or IV classic Hodgkin lymphoma (cHL) in adults and adolescents aged 12 years and older.
Complete list of indications for Nivolumab (Opdivo)
1. Melanoma
Nivolumab as monotherapy is indicated for the adjuvant treatment of stage IIB or IIC melanoma, or melanoma with lymph node metastases or distant metastases that has undergone complete resection, in adults and adolescents aged 12 years and older.
Nivolumab as monotherapy or in combination with Ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents aged 12 years and older.
Compared with Nivolumab monotherapy, the combination of Nivolumab and Ipilimumab has demonstrated improvement in progression-free survival and overall survival only in patients with low tumor PD-L1 expression.
2. Non-small cell lung cancer (NSCLC)
Nivolumab in combination with platinum-doublet chemotherapy is indicated for the neoadjuvant treatment of adult patients with resectable NSCLC at high risk of recurrence and whose tumors have PD-L1 expression ≥1%.
Nivolumab in combination with platinum-doublet chemotherapy as neoadjuvant treatment, followed by Nivolumab monotherapy as adjuvant treatment, is indicated for adult patients with resectable NSCLC at high risk of recurrence and whose tumors have PD-L1 expression ≥1%.
Nivolumab in combination with Ipilimumab and 2 cycles of platinum-doublet chemotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC without EGFR sensitizing mutations or ALK translocations.
Nivolumab as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy.
3. Malignant pleural mesothelioma
Nivolumab in combination with Ipilimumab is indicated for the first-line treatment of unresectable malignant pleural mesothelioma in adult patients.
4. Renal cell carcinoma (RCC)
Nivolumab in combination with Ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced RCC.
Nivolumab in combination with Cabozantinib is indicated for the first-line treatment of adult patients with advanced RCC.
Nivolumab as monotherapy is indicated for the treatment of adult patients with advanced RCC after prior therapy.
5. Classic Hodgkin lymphoma (cHL)
Nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (AVD) is indicated for the treatment of previously untreated stage III or IV cHL in adults and adolescents aged 12 years and older.
Nivolumab in combination with Brentuximab vedotin is indicated for the treatment of relapsed or refractory cHL (after first-line therapy) in children, adolescents aged 5 years and older, and adults under 30 years of age.
Nivolumab 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.
6. Squamous cell carcinoma of the head and neck
Nivolumab as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck that has progressed during or after platinum-based therapy.
7. Urothelial carcinoma
Nivolumab as monotherapy is indicated for the adjuvant treatment of adult patients with muscle-invasive urothelial carcinoma at high risk of recurrence after radical resection, whose tumor cells have PD-L1 expression ≥1%.
Nivolumab in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Nivolumab as monotherapy is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma that has failed prior platinum-based therapy.
8. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)
Nivolumab in combination with Ipilimumab is indicated for the treatment of adult patients with dMMR or MSI-H CRC as:
First-line treatment of unresectable or metastatic CRC;
Treatment of metastatic CRC after prior fluoropyrimidine-based combination chemotherapy.
9. Esophageal squamous cell carcinoma
Nivolumab in combination with Ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma whose tumors have PD-L1 expression ≥1%.
Nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma whose tumors have PD-L1 expression ≥1%.
Nivolumab as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
10. Adjuvant treatment of esophageal or gastroesophageal junction cancer
Nivolumab as monotherapy is indicated for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy.
11. Gastric, gastroesophageal junction, or esophageal adenocarcinoma
Nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative, advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a combined positive score (CPS) for PD-L1 of ≥5.
12. Hepatocellular carcinoma
Nivolumab in combination with Ipilimumab is indicated for the first-line treatment of unresectable or advanced hepatocellular carcinoma in adult patients.
