Landmark Oncology Drug Registration

Landmark Oncology Drug Registration

In what is groundbreaking news for cancer sufferers diagnosed with blood cancers such as multiple myeloma (MM) or myelodysplastic syndromes, Cipla recently received regulatory approval for lenalidomide – a lifesaving immunomodulatory drug that activates and increases the number of immune system cells that identify and attack cancer cells – to bring this medication into the South African market at affordable prices. This will help to ensure that more cancer patients have access to this treatment, in line with Cipla’s ethos of “caring for life”.

This new oncology treatment is poised to make a significant difference in patient’s lives in terms of more affordable access to this critical medication. Because of patent monopolies , the generic was not previously available in South Africa. The cost of this essential drug was prohibitively expensive (ranging between R60 000 to more than R100 000 per month), and many medical aids did not cover the cost in full, meaning patients had to pay out of pocket or the medication was simply unaffordable for most patients. As a result, family members of patients would often travel to India to purchase the same medication at a fraction of the cost.

The introduction of this Cipla oncology drug will address an ethical and moral issue around equitable access to lifesaving medication. In much the same way that Cipla revolutionized HIV by making antiretrovirals available at less than $1 per day compared to over $12,000 per patient per year, lifting the death sentence for millions of people worldwide.

CEO of Cipla South Africa, Paul Miller, said: “About 20 years ago, Cipla brought down the price of antiretrovirals. We see a future where good health is expected – not for the few, but for the many. Therefore, in the same way that Cipla pioneered access to affordable medication for HIV, we hope that by ensuring equitable, affordable access to this critical cancer medication, we make an equally profound difference in patients’ lives.”

Lenalidomide has been proven to delay the progression of the disease in patients with multiple myeloma, and as a result, is sought after worldwide . In addition to its improved efficacy and reduced toxicity profile compared to other drugs, because lenolidomide is an oral therapy, it means less hospital visits to administer treatment2.

According to a report by the World Health Organisation about the pricing of cancer medicines and its impacts, cancer is one of the greatest global public health challenges. “Stakeholders continue to voice their concerns about the lack of adequate access to both new and off-patent essential cancer medicines, with high prices cited as a main contributory factor. Furthermore, overall prices of cancer medicines continue to rise, to the extent of impairing the capacity of health care systems to provide affordable, population-wide access to cancer medicines. ”

In 2018, according to the International Agency for Research on Cancer (Global Cancer Observatory – GLOBOCAN), there were around 1200 new cases of multiple myeloma reported in Southern Africa, however it is believed that this number is under reported5. Myelodysplastic syndromes are not reported separately but rather included with leukaemia cases, so it is not possible to know for certain the number of patients with this condition. Multiple myeloma, also known as plasma cell myeloma and simple myeloma is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Myelodysplastic syndromes are caused by poorly formed blood cells or ones that don’t work properly .

Although still not completely clear as to how this drug gets such good results, it’s thought that besides being an immunomodulatory drug, lenalidomide inhibits the growth of new blood vessels in tumours which causes cancer to progress.

The South African Health Products Regulatory Authority (SAHPRA) has recently registered all strengths of the medicine (5/10/15/20 mg).

Visit the official COVID-19 government website to stay informed: sacoronavirus.co.za
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