Tykerb, the new experimental breast cancer treatment drug has proved so well in the drug trails, that based on its success alone the drug might be made available to patients in the late stages of the disease even before it is approved by the regulators.
It is speculated that Europe's largest drug maker is all set to dominate the world's biggest cancer conference in Atlanta today with information and clinical data on Tykerb. They claim that unlike Roche's $1.8bn-a-year drug, Herceptin, Tykerb can reduce the size of brain tumours caused by breast cancer. This is a problem for 30-40% of the women who suffer from 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. Tykerb is also more convenient than Herceptin, which has to be injected as it is in the form of a pill.
US regulators have permitted GSK to offer Tykerb to doctors who wish to treat women suffering from advanced breast cancer, even before regulatory approval for the full-scale marketing of the pill, which is expected sometime next year. It has been reported that in the UK too, patients could also be treated with Tykerb on "compassionate" grounds.
The final-stage clinical trials have shown that Tykerb, when given to women in combination with the chemotherapy drug Xeloda, considerably slows the development of the cancer, which could almost double the length of time patients live without the disease. The trials were stopped much ahead of schedule last month because Tykerb worked exceptionally well.
With the clinical trials to test Tykerb on early-stage breast cancer will probably take several years to complete, and this makes the path ahead for GSK still very long. Meanwhile, Herceptin has been approved by the European Commission earlier in the week for its use to fight early-stage breast cancer, and is likely to be cleared in the UK soon. This news promises relief to many sufferers, many of whom have fought to get the drug on the NHS, at an estimated cost of £20,000 per patient a year. It is speculated that Tykerb would be far cheaper that Herceptin as it comes on to the market.
GSK's cancer business, which was till 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 that is a blood-clotting agent in the treatment of breast cancer. They are also developing a lung cancer vaccine that would stop the disease from spreading. The pharmaceutical makers have also emerged as the lead runners in the 15bn plus biding for the consumer health care arm of its US rival Pfizer, along with Johnson & Johnson, Reckitt Benckiser and Wyeth. This deal could likely transform GSK into the world's largest maker of non-prescription drugs.
Not wanting to lag behind the Swiss pharmaceuticals giant Roche is also reported to be developing combination treatments that could rival Tykerb. Statistics show that more than 1 million women are diagnosed newly with breast cancer every year worldwide, and about 40,000 in the UK alone.