Swiss pharma major Novartis AG has secured an Indian patent for its skin cancer drug Tafinlar, used in the treatment of metastatic melanoma- the most serious and life-threatening type of skin cancer that is associated with low survival rates.
Tafinlar is a medicine that contains the active substance called Dabrafenib and it is used on its own or in combination with another medicine containing Trametinib on adults, to treat melanoma that has spread to other parts of the body or which cannot be removed by surgery.
Novartis filed the patent application at the Kolkata patent office in 2010 and a request for examination was filed in 2012. The application was examined and first examination report (FER) containing a statement of objections was forwarded in 2015. Novartis’ agent filed the responses to FER in April 2016 and subsequently a hearing was offered in September first week. Having satisfied with Novartis’ submission, Dr S Chattopadhyay, deputy controller of patents & designs, Kolkata, ordered the grant of patent.
Novartis in June this year had announced data from a study showing a significant survival benefit for patients with advanced melanoma when treated with the first-line combination of Tafinlar (Dabrafenib) plus Mekinist (Trametinib) compared to Tafinlar monotherapy.
Combination use of Tafinlar and Trametinib in patients with unresectable or metastatic melanoma is approved in the US, EU, Australia, Canada and additional countries. Tafinlar and Trametinib are also indicated in more than 35 countries worldwide, including the US and EU, as single agents to treat patients with unresectable or metastatic melanoma.
According to studies, only about 20% of people are likely to survive for at least five years following a diagnosis with late-stage disease. There are about 200,000 new cases of melanoma diagnosed worldwide each year. In 2015, as part of its purchase of oncology products from GlaxoSmithKline, Novartis obtained the worldwide exclusive rights granted by Japan Tobacco Inc (JT) to develop, manufacture and commercialise Trametinib.
In September 2015, Novartis received EU approval for Tafinlar plus Trametinib, the first combination therapy approved for patients with unresectable or metastatic melanoma. The approval followed two Phase III trials in which the Tafinlar plus Trametinib combination showed significant overall survival benefit. The US Food and Drug Administration (FDA) approved the combination in late 2015. Novartis is also focusing on the study of a triple combination approach with Tafinlar plus Trametinib and immuno-oncology therapy.
On the flip-side, the patent for company’s flagship cancer drug, Gleevec elapsed and hence lost patent protection in early 2016.