GSK has Tafinlar ‘breakthrough’
pharmafile | January 15, 2014 | News story | Sales and Marketing | Cancer, FDA, GSK, NSCLC, Tafinlar
GlaxoSmithKline is on a roll, with its cancer drug Tafinlar given breakthrough therapy designation by the FDA in lung cancer just days after the US regulator approved it in skin cancer.
Tafinlar (dabrafenib) has been granted its new status for the treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy.
The drug is not approved anywhere in the world in this setting – but the FDA has taken a shine to Tafinlar, approving it last week in combination with GSK’s Mekinist to treat advanced melanoma.
Lung cancer is the second most common cancer in both men and women, and the NSCLC move means that the therapy will be fast-tracked – it also indicates that the FDA believes it “may have substantial improvement on at least one clinically significant endpoint over available therapies”.
This view is based on interim data from an ongoing Phase II study of the drug given orally to 25 patients who had NSCLC with the BRAF V600E mutation, and who had received chemotherapy.
Genetic mutations such as those in the BRAF protein, can drive malignant cell growth and tumour proliferation in NSCLC.
The FDA’s approval of Tafinlar in combination with GSK’s own Mekinist (trametinib) to treat patients with advanced melanoma that either cannot be removed by surgery or is metastatic, came after they were granted priority review status in September together.
Both were separately approved earlier in 2013 for the treatment of inoperable or metastatic melanoma with BRAF protein mutations: MEK inhibitor Mekinist tackles both the V600E and V600K mutations.
The National Cancer Institute estimated that 76,690 Americans would be diagnosed with melanoma, and 9,480 would die from the disease in 2013.
There is a relatively high incidence rate among 15- to 34-year-olds and diagnoses have quadrupled over the last 30 years.
Melanoma is the deadliest form of skin cancer, according to the World Health Organisation.
Adam Hill
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