FDA approves GSK cancer drugs
pharmafile | May 30, 2013 | News story | Sales and Marketing | FDA, GSK
The FDA has approved two of GlaxoSmithKline’s cancer pills: BRAF-inhibitor Tafinlar and the first validated MEK-inhibitor, called Mekinist, both of which allow patients to live longer without their disease worsening.
Analysts have already predicted peak annual sales for Tafinlar (dabrafenib) and Mekinist (trametinib) to reach £1.5 billion ($2.4 billion) by 2020 and the drugs will be available “no later than in the early third quarter of 2013”.
Tafinlar is indicated to treat melanoma that is either metastatic or cannot be removed by surgery in adults with BRAF V600E mutation – a gene abnormality that can enable some tumours to grow and spread – although it is not approved for the wild-type BRAF melanoma.
In trials median progression-free survival (PFS) for Tafinlar patients was 5.1 months compared to 2.7 months with chemotherapy agent dacarbazine.
Meanwhile Mekinist is indicated on its own for unresectable or metastatic melanoma in adults with BRAF V600E or V600K mutations – but not if they have received a prior BRAF inhibitor therapy.
Median PFS for Mekinist patients in trials was 4.8 months versus 1.5 months for chemotherapy.
The brands will cover a sizeable chunk of cancer patients: half of those with metastatic melanoma have a BRAF mutation, while the BRAF V600E mutation accounts for around 85% of all BRAF V600 mutations in metastatic melanoma.
The V600K mutation for which Mekinist is also approved makes up 10% of all BRAF V600 mutations in metastatic melanoma.
“GSK can now offer two new single-agent therapies to selected patients who have metastatic melanoma, a devastating disease with very low survival rates and few treatment options,” said Paolo Paoletti, president, GSK Oncology.
GSK already collaborates with bioMérieux on a companion diagnostic test to detect BRAF V600 (V600E and V600K) and bioMérieux has received FDA pre-market approval for THxID-BRAF, which picks up the V600K mutation.
Roche’s Zelboraf (vemurafenib) had been the only licensed drug to treat BRAF positive melanoma patients and was the first drug to increase overall survival in this patient population.
A Phase III trial is to combine the GSK drugs to which the FDA has just singly given the green light and pit them against Zelboraf.
Adam Hill
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