European Commission Approves Opdivo (Nivolumab) Four-Week Dosing Regimen for Adjuvant Treatment of Melanoma
Bristol-Myers Squibb
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European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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On October 24, Bristol-Myers Squibb announced that the European Commission had approved two dosing regimens of Opdivo for adjuvant treatment in patients with node-positive or metastatic melanoma following complete surgical resection. The approved regimens are: (1) 240 mg administered via intravenous infusion over more than 30 minutes every 2 weeks; and (2) 480 mg administered via intravenous infusion over more than 60 minutes every 4 weeks.
This approval marks a significant milestone for melanoma patients across the European Union, providing them with flexible adjuvant therapy options better tailored to individual needs to help control the disease and regain control over their lives.
In late March this year, the European Union approved the every-six-weeks (Q6W) dosing regimen for Merck & Co.’s tumor immunotherapy Keytruda for all approved monotherapy indications, covering eight indications across five cancer types, including non-small cell lung cancer, melanoma, bladder cancer, head and neck cancer, and classical Hodgkin lymphoma. Compared with the currently approved 200 mg every-three-weeks regimen, the Q6W dosing regimen (with an infusion time of no less than 30 minutes) offers a more patient-friendly treatment option, reducing the frequency of administration and providing greater treatment flexibility for patients and oncologists.
Melanoma is a type of skin cancer characterized by the uncontrolled growth of melanocytes within the skin. Metastatic melanoma occurs when cancer cells spread from the skin surface to other organs, representing the most lethal form of the disease. Melanoma is classified into five stages (Stage 0–4) based on the primary tumor characteristics, thickness and ulceration status, whether the tumor has spread to lymph nodes, and the extent of spread beyond the lymph nodes.
Stage III melanoma has typically spread to regional lymph nodes but not to distant lymph nodes or other parts of the body (metastasis). Surgical resection of the primary tumor and involved lymph nodes is required. Despite surgical intervention, most patients still experience disease recurrence and metastasis. Some patients may receive adjuvant therapy after surgery, aiming to eliminate residual micrometastases, reduce the risk of tumor recurrence and metastasis, and improve cure rates.
Currently, melanoma is largely curable when treated in its early stages; however, if it involves regional lymph nodes (Stage III), the survival rate decreases by approximately half. For advanced melanoma (Stage IV), the 5-year survival rate is 15–20%, and the 10-year survival rate is 10–15%. Early intervention with adjuvant therapy has been proven to be a critical factor in reducing the risk of postoperative recurrence in high-risk Stage III melanoma.
Opdivo was approved in July 2014 as the world’s first PD-1 immunotherapy. To date, it has been approved in more than 65 countries for the treatment of various types of cancer. In October 2015, the Opdivo plus Yervoy immunotherapy combination was approved as the first immuno-oncology combination regimen for the treatment of metastatic melanoma; this regimen has now been approved in more than 50 countries.
In terms of melanoma, the approved indications for Opdivo include: ① as monotherapy or in combination with Yervoy for the treatment of patients with unresectable or metastatic melanoma; ② adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease.
In China, Opdivo is the first approved cancer immunotherapy, having received approval in June 2018 for the treatment of patients with previously treated non-small cell lung cancer (NSCLC). In early October this year, Opdivo was approved by the National Medical Products Administration (NMPA) for an expanded indication: the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) whose disease has progressed during or after platinum-based therapy and whose tumors express PD-L1 (≥1% of tumor cells expressing PD-L1).
It is worth noting that Opdivo is the first PD-1 inhibitor approved in China for the treatment of head and neck squamous cell carcinoma (HNSCC), as well as the first monotherapy demonstrated in Phase III clinical trials to significantly improve overall survival and quality of life in patients with HNSCC. Compared with standard therapy, Opdivo reduces the risk of death by 32% and nearly triples the 2-year survival rate. Currently, Opdivo has been recommended as a second-line treatment for HNSCC in authoritative clinical guidelines both domestically and internationally.
References:
1、European Commission Approves Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection
2. Merck’s Patient-Friendly Six-Week Dosing Regimen for Keytruda Approved in the EU
3. China’s First Immuno-Oncology Drug, Opdivo®, Approved for Expanded Indication in Patients with Head and Neck Squamous Cell Carcinoma
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.