GSK’s Tyverb granted conditional licence in EU
pharmafile | June 13, 2008 | News story | Sales and Marketing |
European regulators have given GlaxoSmithKline's Tyverb conditional approval, clearing it for launch but asking for more clinical data.
Tyverb (lapatinib) was originally approved by the EMEA earlier this year, but concerns over liver side effects emerged shortly afterwards, prompting the regulator to re-assess it.
The company must now provide further trial data and conduct an additional clinical study. European regulators will then review new information annually and update the product information as necessary.
The breast cancer drug has been touted as the company's first oncology blockbuster, but the regulator's decision could make it difficult for GSK to promote the drug.
Tyverb's conditional licence covers its use in advanced or metastatic ErbB2 or HER2 positive breast cancer in combination with Xeloda (capacitabine). Patients should have already been treated with anthracyclines and taxanes and, in the metastatic setting, Herceptin (trastuzumab).
Professor David Cameron, director of National Cancer Research Network and co-principle investigator of Tyverb's pivotal phase III trial said the drug's approval would benefit women across Europe with HER2-positive advanced or metastatic breast cancer.
"Lapatinib will play a valuable role in treating this especially aggressive form of advanced breast cancer, with the added benefit of being a pill rather than needing intravenous administration," he added.
Tyverb's ease of administration, along with a potentially more favourable safety profile and cheaper production costs compared to Herceptin might allow it to eventually challenge Roche's top-selling breast cancer drug.`
But although the drugs target the same group of HER2-positive patients, which make up around 25-30% of all women suffering from breast cancer, Herceptin is very well established and GSK would face an uphill struggle to win market share.
Tyverb is currently being evaluated on its own and in combination with other therapies against a number of other ErbB2-positive breast cancers, from metastatic to early-stage.
GSK also has ongoing or planned trials in a range of other solid tumours that over-express ErbB1 and/or ErbB2, including gastric and head and neck cancer.
The global head of GSK's Oncology Medicine Development Centre, Dr Paolo Paoletti said: "With numerous clinical trials assessing lapatinib across a range of tumour types, we hope this is just the beginning for this innovative product, in terms of the positive difference it can make to patients' lives."
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