New cancer therapy

One of our active contributors, Ana Parvulescu, is back with valuable information especially to health professionals, but limited to. She brings the latests news on the treatment of melanoma and lung cancer.

With the help of Ana and a few other contributors that you will soon meet on farmacist.info, we aim to bring specialised information for pharmacists, doctors and healthcare professionals. However, if you want to know the latestest news from European Medicines Agency (EMA) and Food and Drug Administration (FDA), our new category PRO is available to everybody.

Advanced melanoma

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Keytruda (pembrolizumab). It is recommended as monotherapy for the treatment of adult patients with advanced melanoma that cannot be surgically removed or where the cancer has spread to other parts of the body (unresectable or metastatic melanoma).

Melanoma is the most aggressive form of skin cancer and the leading cause of death from skin disease. The main risk factor for developing melanoma is ultraviolet (UV) light and intermittent exposure to the sun. In 2012 more than 100,000 Europeans were diagnosed with melanoma and around 22,200 were estimated to have died from the disease.

If melanoma is detected early, it can often be removed by surgery and patients have a very good chance of survival. However, patients with advanced melanoma have a poor prognosis. It is estimated that five years after diagnosis of advanced melanoma only 10 to 30% of patients will still be alive.

Melanoma stages

Fig. 1 Identifying melanoma

For decades, standard chemotherapy was the only available treatment for patients with advanced melanoma. However, this therapy has limited benefits for patients with this disease. In the last three years, the authorisation of targeted treatments, including monoclonal antibodies, BRAF V600 inhibitors and MEK inhibitors, have significantly changed the therapeutic landscape and increasingly benefited patients. However, there are still important unmet medical needs for this condition and the availability of new treatment options continues to be essential to improve the outlook for patients.

Keytruda’s active ingredient is pembrolizumab, a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody. Pembrolizumab is a type of immunotherapy, which works by blocking a cellular pathway that limits the immune system from fighting melanoma cells. By blocking this pathway, pembrolizumab enables the body’s own immune system to fight the disease.

Studies show that pembrolizumab is efficient not just for the patients that were previously treated with ipilimumab, but also for the patients that were not previously treated with ipilimumab (melanoma imunotherapy). Pembrolizumab is also safe for the patients.

Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system.

Advanced lung cancer

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Nivolumab BMS (nivolumab). Nivolumab BMS can be used to treat adult patients with a type of lung cancer called squamous non-small cell lung cancer (NSCLC), when the disease is advanced, and has already been treated with chemotherapy. It is the first immunotherapy medicine recommended for approval for squamous NSCLC in the European Union (EU).

In April 2015, EMA recommended for approval another nivolumab-containing medicine, Opdivo, for the treatment of patients with advanced (unresectable or metastatic) melanoma.

Lung cancer is among the most common cancers in the world. Approximately 85% of all lung cancers are NSCLCs, which are frequently further subdivided into non-squamous and squamous cell carcinoma. Most patients with NSCLC are found to have advanced disease at the time of diagnosis, and patients are generally treated with chemotherapy and/or radiation. These treatments, however, rarely cure the disease and the disease often reoccurs or progresses. Although more medicines have become available in recent years for NSCLC, these do not generally help people with squamous NSCLC. The treatment options for patients with squamous NSCLC whose disease reoccurs or progresses despite chemotherapy are limited.

Lung Anatomy

Fig. 2 Lung anatomy with the first signs of cancer development

The active substance in Nivolumab BMS, nivolumab, is a monoclonal antibody. Nivolumab attaches to and blocks a receptor called ‘programmed death-1’ (PD-1). By blocking the usual receptor interactions, Nivolumab BMS leads to activation of the immune system against cancer cells.

Studies show that after 12 months of treatment, 42% of the patients that were treated with nivolumab are still alive, comparing to only 24% of the patients that were treated with docetaxel (a commonly used type of chemotherapy).

Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system.


References:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/05/news_detail_002334.jsp&mid=WC0b01ac058004d5c1

https://en.wikipedia.org/wiki/BRAF_(gene)

http://www.ncbi.nlm.nih.gov/pubmed/22554099

http://www.ema.europa.eu/docs/ro_RO/document_library/EPAR_-_Summary_for_the_public/human/002213/WC500109303.pdf

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/05/news_detail_002335.jsp&mid=WC0b01ac058004d5c1


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