GlaxoSmithKline's experimental breast cancer treatment, Tykerb, has proved so successful in drug trials it will be made available to patients in late stages of the disease, even before it gets the nod from regulators.
Europe's largest drug maker is set to dominate the world's biggest cancer conference in Atlanta today with data on Tykerb. Unlike Roche's $1.8bn-a-year drug, Herceptin, Tykerb can reduce the size of brain tumours caused by breast cancer, a problem for 30 to 40 per cent of women with the aggressive, recurring form of the cancer. The data also demonstrates that Tykerb works on patients where Herceptin has failed, and shows a significant increase in life expectancy. As a pill, Tykerb is also more convenient than Herceptin, which has to be injected.
US regulators have allowed GSK to offer Tykerb to doctors who wish to treat women suffering from advanced breast cancer, before regulatory approval for full-scale marketing of the pill, which is expected sometime next year. In the UK, patients could also be treated with Tykerb on "compassionate" grounds.
Final-stage clinical trials have shown that Tykerb, when given to women in combination with the chemotherapy drug Xeloda, slows the development of the cancer, nearly doubling the length of time patients live without the disease. The trials were stopped ahead of schedule last month because Tykerb worked so well.
But GSK still has a long way to go. Clinical trials to test Tykerb on early-stage breast cancer will take several years. Meanwhile, Herceptin was approved by the European Commission this week to fight early-stage breast cancer, and is likely to be cleared in the UK soon. That promises relief to many sufferers, some of whom have fought to get the drug on the NHS, at an estimated cost of £20,000 per patient a year.
Tykerb is believed to be far cheaper than Herceptin once it comes on to the market.
The Swiss pharmaceuticals giant Roche is developing combination treatments that could rival Tykerb. More than 1 million women are newly diagnosed with breast cancer every year worldwide - about 40,000 in the UK.
GSK's cancer business, until now relatively small, is likely to be transformed next year with the launch of Tykerb and other blockbuster drugs, such as the cervical cancer vaccine Cervarix and Eltrombopag, a blood-clotting agent in the treatment of breast cancer. The group is also developing a lung cancer vaccine that would stop the disease spreading.
The drug maker has emerged as one of the front-runners in the $15bn-plus bidding for the consumer healthcare arm of its US rival Pfizer, along with Johnson & Johnson, Reckitt Benckiser and Wyeth. The deal would transform GSK into the world's largest maker of non-prescription drugs. Second-round bids have to be in by Tuesday.