Pembrolizumab that formerly named MK-3475 and Lambrolizumab with the trade name Keytruda is a humanized antibody used in cancer immunotherapy.
It was approved for the treatment of melanoma, certain subsets of colorectal cancer, head and neck cancers, metastatic bladder cancer, certain types of lung cancer, and a few other malignancies and has shown effectiveness with many mesothelioma patients.
Pembrolizumab blocks a protective mechanism of cancer cells and allows the immune system to destroy those cancer cells. Pembrolizumab is the first approved cancer drug by the FDA based on tumor genetics rather than tissue type or tumor site.
Keytruda price for each indicated dose of it when given every 6 weeks is $20,134.72.
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In 2006: Medical Research Council Technology (now known as LifeArc) started to humanize the antibody and at the end of this research, scientists Gregory Carven, Hans van Eenennaam, and John Dulos invented Pembrolizumab.
In 2010: The development has been finished and Merck began preparing to out-license it.
In 2011: Phase I of the study started in early 2011, and around 1300 people participated in the trial; it was the largest Phase I study ever run in oncology with the patients roughly divided between melanoma and lung cancer.
In 2013: The name of the drug changed from Lambrolizumab to Pembrolizumab.
In 2014: Pembrolizumab was approved by the FDA for use in treatment with Ipilimumab, or after treatment with Ipilimumab and a BRAF inhibitor in advanced melanoma patients who carry a BRAF mutation.
In July 2015: It received marketing approval in Europe.
In 2016: It received marketing approval in Japan and signed a co-promoting agreement with Taiho Pharmaceutical.
In 2015: It was approved by the FDA for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have failed treatment with other chemotherapeutic agents
In July 2016: The US FDA approved Pembrolizumab as a treatment for patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
In May 2017:
- It was approved by chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC).
- FDA Approved Merck’s Pembrolizumab for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
In June 2018: the FDA approved Pembrolizumab for the treatment of advanced cervical cancer for PD-L1 positive patients and also for patients with refractory primary mediastinal large B-cell lymphoma (PMBCL). this approval started Pembrolizumab trading by clinical trial product distributors.
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Pembrolizumab is used to treat:
- Unresectable or metastatic melanoma
- Metastatic non-small cell lung cancer (NSCLC)
- Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
- Refractory classical Hodgkin Lymphoma (CHL)
- Locally advanced or metastatic Urothelial Carcinoma
- Primary mediastinal B-cell lymphoma (PMBCL).
- Gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Cervical cancer
Pembrolizumab is classified as a monoclonal antibody that is a relatively new type of “targeted” cancer therapy. It binds to the PD-1 ( programmed cell death protein 1 located on lymphocytes) receptor and deactivated it so that its interaction with the ligands, PD-L1 and PD-L2 will be blocked.
As a result of this binding, T-cell–mediated immune responses will be activated against tumor cells. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
The binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production.
Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to the inhibition of active T-cell immune surveillance of tumors.
The function of this receptor is to prevent the immune system from attacking the body’s own tissues; it is a so-called immune checkpoint. Most cancers make proteins that bind to PD-1 and shut down the ability of the body to kill the cancer cells. Blocking PD-1 allows the immune system to target and destroy cancer cells.
The same mechanism allows the immune system to attack the body itself; Pembrolizumab is a type of checkpoint inhibitor with immune-dysfunction side effects.
- Normal immune response
When functioning properly, T cells are activated and can attack tumor cells.
- Tumor ivasion and T-cell deactivation
Some tumors can evade the immune system through the PD-1 pathway. The PD‑L1 and PD‑L2 ligands on tumors can bind with PD-1 receptors on T cells to inactivate the T cells.
- T-cell reactivation with Keytruda
Pembrolizumab binds to the PD-1 receptor and blocks its interaction with PD‑L1 and PD‑L2, which helps restore the immune response. While having an effect on the tumor, this could also affect normal healthy cells.
It is expected that the market size of cancer immunotherapies grows more than fourfold from $16.9 billion in 2015 to $75.8 billion by 2022 and representing a rapid compound annual growth rate (CAGR) of 23.9%.
Established immunotherapies, particularly Revlimid, Opdivo, Keytruda, and Gazyva, will show rapid sales growth throughout the forecast period, with Keytruda and Opdivo rising by $7 billion and $9 billion, respectively.
It is anticipated that the global immune checkpoint inhibitors market cross US$ 25 Billion by 2022. The global immune checkpoint inhibitors market has been divided into PD-1, PD-L1, and CTLA-4 on the basis of the type of product.
It is estimated that PD-1 be the largest share in 2016. On the basis of the type of cancer, Lung Cancer & Melanoma will be the nominated type in the market.
In the following figure, the Sales forecast by Keytruda exporters will be shown in the seven major markets (United States, France, Germany, Italy, Spain, the United Kingdom, and Japan) from 2013 to 2020.
Figure 1: Major-market sales of select immune checkpoint inhibitors (estimated).