GlaxoSmithKline’s Tyverb has been cleared in the EU for use in combination with Roche’s Herceptin in patients with HER2-positive, hormone receptor-negative breast cancer.
Approval was based on the results of the EGF104900 trial, which compared Tyverb (lapatinib) plus Herceptin (trastuzumab) to Tyverb alone and found the combination therapy resulted in a significant eight-month increase in overall survival over Tyverb given alone.
Tyverb acts as an intracellular inhibitor of HER2, while Herceptin binds to the extracellular portion of the receptor and it is thought that employing them in tandem achieves better blockade than either drug used alone.
GSK Oncology president Paolo Paoletti said the EU approval “is important for women with this specific type of metastatic breast cancer, who will have now a new treatment option”.
Tyverb and Herceptin represent a ‘chemotherapy-free’ approach to breast cancer, which “has the potential to make a positive impact on the care and survival of these patients,” he added.
The combination has also been approved in the Philippines, Russia and Thailand, but ran into a regulatory block in the US.
Last year, GSK withdrew its application for use of the combination in patients who had previously been treated with Roche’s drug in the US (where lapatinib is sold as Tykerb) after the FDA asked for more data.
GSK had high hopes for Tykerb when it was first launched in 2007 as an oral alternative to injectable Herceptin, but sales have never lived up to early expectations and the company has struggled to expand the market for the drug.
First half 2013 sales were just £105m ($164m), a fraction of the $3.33bn Herceptin brought in during the same period, and GSK has faced a series of setbacks trying to extend its indications.
In June the company reported disappointing results for Tyverb in a gastric cancer trial, while last year it withdrew an EU application seeking approval in combination with paclitaxel in patients with metastatic HER2-positive breast cancer.
Meanwhile, a trial of the drug as an adjuvant therapy in early breast cancer failed to show a significant improvement in progression-free survival (PFS) compared to placebo.