Oncology

Opdivo (Nivolumab) in Danohealth view

Opdivo in Dano Health

Opdivo (Nivolumab) in Dano Health view

Opdivo under the generic name Nivolumab was discovered at Medarex and developed by Medarex and Ono Pharmaceutical medicine supplier. Bristol-Myers Squibb, the American pharmaceutical wholesaler company, and Ono together have brought this drug to the market.

Opdivo in Dano Health

Opdivo in Dano Health

History

In 2014: Scientists at Medarex, American biopharmaceutical supplier company,  created Nivolumab by using Medarex’s transgenic mice with a humanized immune system. It was also approved by the FDA as the treatment of Advanced Melanoma.  Japanese regulatory authorities approved Nivolumab for the treatment of gastric cancer; It was the first regulatory approval of a PD-1 inhibitor anywhere in the world.

In 2015: it was recommended to approve Nivolumab for metastatic melanoma as a monotherapy.  It was approved by the US FDA for the treatment of advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. During the same year,  it was approved by the FDA as a second-line treatment for renal cell carcinoma after having granted the application breakthrough therapy designation, fast-track designation, and priority review status.

In 2016: it was approved by the FDA  as the treatment for patients with classical Hodgkin lymphoma (CHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation Brentuximab Vedotin.

In 2017: Nivolumab received the FDA approval for adjuvant treatment of melanoma with the involvement of lymph nodes or for metastatic disease with complete resection.

In 2018: Nivolumab was approved by the FDA as a combined medication (with Ipilimumab) for the first-line treatment of intermediate and poor risk advanced renal cell carcinoma patients.

In 2018: China’s Drug Administration approved Nivolumab for Previously Treated Non-Small Cell Lung Cancer (NSCLC); it was this country’s first immuno-oncology and the first PD-1 therapy.

Medical use

Opdivo is a cancer medicine containing the active substance Nivolumab. It can be given alone or in combination with other cancer medicines.

It is indicated as a single agent for the treatment of:

  • BRAF V600 wild type unrespectable or metastatic melanoma
  • BRAF V600 mutation-positive unresectable or metastatic melanoma
  • metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy
  • advanced renal cell carcinoma with prior anti-angiogenic therapy.
  • classical Hodgkin lymphoma in adults
  • recurrent or metastatic squamous cell carcinoma of the head and neck
  • locally advanced or metastatic urothelial carcinoma
  • microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer

It  is indicated as a combined medicine ( in combination with Ipilimumab)  for the treatment of:

  • melanoma with lymph node involvement or metastatic disease
  • unresectable or metastatic melanoma
  • untreated advanced renal cell carcinoma

Mechanism of action

Opdivo works with the immune system to treat cancer. The active substance in Opdivo is Nivolumab; this monoclonal antibody is a protein that has been designed to recognize and attach to PD-1(programmed death receptor-1), a receptor (target) on cells of the immune system called T cells. These receptor proteins block killing a cell when it interacts with ligands called PD-L1 and PD-L2. Some tumor cells produce PD-L1 (programmed death-ligand 1) and PD-L2 (programmed death-ligand 2) to disrupt the PD-1 pathway and therefore evade T-cells, preventing them from attacking cancer.  Nivolumab attaches to this receptor and prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the immune system’s ability to kill cancer cells.

  1. Normal Immune Response: T-cell activation and tumor attack

  1. Tumor Immune Evasion: T-cell inactivation through the PD-1 immune checkpoint

 

  1. Normal Immune Response Restored:

T-cell reactivation and decreased tumor growth* through PD-1 immune checkpoint inhibition. Besides having an effect on the tumor, this could also affect normal cells.

Market

In 2017, the U.S. FDA (Food and Drug Administration) approved Opdivo as adjuvant therapy for individuals with melanoma with the involvement of lymph nodes or metastatic disease who have undergone complete resection to reduce the risk of recurrence after surgical removal of the tumor.

Bristol-Myers Squibb, the Opdivo trader, has modernized the using of immune checkpoint inhibitors for the adjuvant treatment of melanoma. In the melanoma drugs market, some important drugs like Roche’s (RHHBY) Cotellic and Zelboraf, Novartis’s (NVS) Tafinlar+Mekinist, and Merck’s (MRK) Keytruda. Opdivo sales growth could boost the Vanguard Total Stock Market ETF (VTI). This company makes up about 0.38% of VTI’s total portfolio holding.

Chief executive Giovanni Caforio reported that Opdivo has a market share of 80% in the US in the PD-1 inhibitor category – currently its only rival in the space is Merck & Co with Keytruda (Pembrolizumab) – as well as “comparable” positions in other markets including Japan, Germany, and France.
Opdivo and Keytruda as immunotherapies have changed the cancer treatment landscape, trial results have shown that these potent therapies need to be targeted to the right patient populations to have the greatest impact.

Opdivo had been considered the market leader that rapidly gaining approval for indications — melanoma, second-line non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck.  This drug Initially approved in 2014. Opdivo’s sell reached  $1 billion in 2015, jumping to sales of $3.8 billion in 2016. Rather, Keytruda brought in only $566 million in 2015 and hit $1.4 billion in 2016. Opdivo seemed unstoppable, and Merck’s Keytruda seemed forever on its heels.

Credit: BioPharma Dive; company quarterly reports

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