Advisors to the European Medicines Agency have issued positive opinions for two of GlaxoSmithKline’s cancer drugs, bringing them a huge step closer to winning regulatory approval.
First up is GSK’s new renal cell carcinoma candidate Votrient (pazopanib), an angiogenesis inhibitor which, as well as starving the tumour of oxygen and essential nutrients, also acts on the actual cause of the disease.
The firm has high hopes that its once-daily pill will offer an effective new oral targeted therapy for patients with RCC, the most common form of kidney cancer which kills nearly 30,000 people a year in Europe alone.
Following its assessment the Committee for Medicinal Products for Human Use has recommended that the EMA award Votrient conditional marketing approval for the first-line treatment of RCC and patients who have already received cytokine therapy for advanced disease.
Its decision comes on the back of Phase III trial results showing that the drug significantly improved progression-free survival compared to placebo – 9.2 months versus 4.2 months overall – in patients with advanced kidney cancer who were either treatment naive or had failed to respond to a prior cytokine-based therapy.
Conditional marketing approvals can be issued to drugs with a positive benefit-risk assessment if they fulfil an unmet medical need, as long as the expected benefits of their immediate availability outweigh the risk inherent in the fact that additional data are still required for a full green light.
As such, GSK will be required to provide further data from its ongoing study comparing Votrient with Pfizer’s rival kidney cancer drug Sutent (sunitinib) to satisfy the requirements of conditional authorisation, if granted.
The CHMP also issued a positive opinion for a new therapeutic indication for Tyverb (lapatinib), recommending that the drug be given the green light for the treatment of post-menopausal women with hormone receptor positive, HER2 (ErbB2) over-expressing metastatic breast cancer, and for whom chemotherapy is currently not intended, alongside an aromatase inhibitor.
A combination of Tyverb – which GSK notes is the first oral, small-molecule, dual-targeted therapy for metastatic breast cancer that over-express ErbB2 – and the chemotherapy capecitabine is already authorised in more than 90 countries for the treatment of patients with advanced or metastatic breast cancer whose tumours over-express ErbB2.
Again, the CHMP’s favour is based on Phase III results demonstrating that a combination of Tyverb and the AI letrozole provided a significant improvement in progression-free survival compared to letrozole alone (8.2 months compared with three months).
‘Rapid pace’ of development
GSK notes that the CHMP has in the last three months issued four innovative cancer and haematology treatments researched and developed by the firm. “We are proud that the rapid pace of our development programme is delivering products that may make a difference for those patients who continue to try and overcome these two types of cancers, which are challenging diseases to treat,” commented Eddie Gray, President, GSK Pharmaceuticals Europe.
However, while shareholders will undoubtedly have welcomed the news, the group’s stock closed down on the London Stock Exchange on Friday, perhaps because of new restrictions placed on the use of long-acting beta agonists including GSK’s Advair (salmeterol and fluticasone) for the treatment of asthma across the pond, closely followed by a leaked US Food and Drug Administration report – obtained by the New York Times – which claims the group’s diabetes drug Avandia (rosiglitazone) significantly increases the chances of heart damage.
