As the year draws to a close, there is just time to reflect on the past 12 months and to highlight those companies and drugs that have triumphed and failed. With only seven major new drug approvals in the US and Europe, compared to 11 in 2007, it would seem that the pharmaceutical industry and regulators are suffering from the knock-on effects of the current financial climate, where prudence is now key.
The year got off to a good start, when in January the EC granted marketing approval to Abraxis BioScience's Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. The first US approval came in the form of Cephalon's Treanda (bendamustine) for Injection, for the treatment of patients with chronic lymphocytic leukaemia (CLL) in March. Later in the year, the FDA also approved bendamustine for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. In October, the EC granted a full marketing authorisation, in the form of a positive Commission Decision, for EpiCept's Ceplene (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with acute myeloid leukaemia in first remission.
The major winners of 2008 were definitely in the field of supportive care for cancer. In January, the EC and FDA approved Merck & Co's fosaprepitant dimeglumine (MK-0517) for Injection, an intravenous therapy for the prevention of chemotherapy (CT)-induced nausea and vomiting (CINV). Available as Emend in the US and Ivemend in the EU, the drug was approved for use in combination with other anti-emetic medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately- and highly-emetogenic cancer CT. A further approval came in September, as the FDA approved ProStrakan's Sancuso (granisetron), a novel, patent-protected transdermal patch for the prevention of CINV; the product was launched in the US in November.
Another approval to support cancer patients came in April when the EC granted marketing authorisation to Cephalon's Effentora, a buccal tablet formulation of fentanyl, for the treatment of breakthrough cancer pain in adult patients who are already receiving maintenance opioid therapy for chronic pain. More good news came as both the FDA and EC approved Progenics Pharmaceuticals/Wyeth Pharmaceuticals' Relistor (methylnaltrexone injection), in April and July, respectively, for subcutaneous use for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. In what could be the final approval of the year, in December, the FDA granted marketing authorisation to Genzyme's Mozobil (plerixafor injection), a drug intended to be used in combination with G-CSF to mobilise haematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with NHL and multiple myeloma. Hopefully 2009 will be a more fruitful year.
Matthew Dennis - Editor, Cancer Drug News
Thursday, December 18, 2008
Cancer to lead death toll in 2010?
Despite the fact that cancer incidence and death rates for men and women in the developed world continue to decline, cancer is projected to become the leading cause of death worldwide in the year 2010, and low- and middle-income countries will feel the impact of higher cancer incidence and death rates more sharply than industrialised countries.
To coincide with the International Agency for Research on Cancer releasing the new edition of the World Cancer Report, in the US, the nation's leading cancer organisations joined forces at an event called Conquering Cancer: A Global Effort, to focus attention on the growing global cancer burden and discuss efforts needed to address the problem. The American Cancer Society, the Lance Armstrong Foundation and Susan G. Komen for the Cure discussed how each organisation is addressing the global cancer problem and together issued a call to action for the incoming US presidential administration and Congress.
According to the report, the burden of cancer doubled globally between 1975 and 2000. It is estimated that it will double again by 2020 and nearly triple by 2030. This translates to far greater numbers of people living with and dying from the disease. The report estimates that there were some 12 million new cancer diagnoses worldwide in 2008, and more than 7 million people will die from the disease.
The projected numbers for the year 2030 are 20 to 26 million new diagnoses and 13 to 17 million deaths. The growing cancer burden includes global increases of incidence of approximately 1 per cent each year, with larger increases in China, Russia and India. Reasons for the increased rates include adoption of Western habits in less developed countries, such as tobacco use and higher-fat diets, and demographic changes, including a projected population increase of 38 per cent in less developed countries between 2008 and 2030. In addition to increases in cancer incidence and death rates, the report identifies challenges in cancer care, especially in Africa, where pain management and palliative care are very limited because any use of narcotics is prohibited by law in several countries.
The call to action steps issued by the three organisations include: 1) making vaccines that prevent cancer-causing infections more widely available to low-income nations, including efforts to make the human papillomavirus vaccine accessible and affordable; 2) committing to a comprehensive tobacco control approach in the US, which includes taking measures proven effective in reducing smoking rates and having Congress grant the FDA authority to regulate tobacco; 3) ratifying immediately the Framework Convention on Tobacco Control, the first ever global public health treaty that sets forth comprehensive measures to reduce health and economic impacts of tobacco; 4) supporting efforts of non-governmental organisations to build advocacy and resources, empower survivors and reduce suffering in low- to middle-income countries by working with governments, medical professionals and the corporate sector to enable individuals to adopt healthier behaviours; 5) promoting culturally-sensitive risk reduction and education campaigns by leveraging US efforts to help build capacity of non-governmental organisations in other countries; and 6) investing in cancer research and expanding access to prevention and early detection measures in the US, with a specific focus on increasing federal funding of medical research.
Matthew Dennis - Editor, Cancer Drug News
To coincide with the International Agency for Research on Cancer releasing the new edition of the World Cancer Report, in the US, the nation's leading cancer organisations joined forces at an event called Conquering Cancer: A Global Effort, to focus attention on the growing global cancer burden and discuss efforts needed to address the problem. The American Cancer Society, the Lance Armstrong Foundation and Susan G. Komen for the Cure discussed how each organisation is addressing the global cancer problem and together issued a call to action for the incoming US presidential administration and Congress.
According to the report, the burden of cancer doubled globally between 1975 and 2000. It is estimated that it will double again by 2020 and nearly triple by 2030. This translates to far greater numbers of people living with and dying from the disease. The report estimates that there were some 12 million new cancer diagnoses worldwide in 2008, and more than 7 million people will die from the disease.
The projected numbers for the year 2030 are 20 to 26 million new diagnoses and 13 to 17 million deaths. The growing cancer burden includes global increases of incidence of approximately 1 per cent each year, with larger increases in China, Russia and India. Reasons for the increased rates include adoption of Western habits in less developed countries, such as tobacco use and higher-fat diets, and demographic changes, including a projected population increase of 38 per cent in less developed countries between 2008 and 2030. In addition to increases in cancer incidence and death rates, the report identifies challenges in cancer care, especially in Africa, where pain management and palliative care are very limited because any use of narcotics is prohibited by law in several countries.
The call to action steps issued by the three organisations include: 1) making vaccines that prevent cancer-causing infections more widely available to low-income nations, including efforts to make the human papillomavirus vaccine accessible and affordable; 2) committing to a comprehensive tobacco control approach in the US, which includes taking measures proven effective in reducing smoking rates and having Congress grant the FDA authority to regulate tobacco; 3) ratifying immediately the Framework Convention on Tobacco Control, the first ever global public health treaty that sets forth comprehensive measures to reduce health and economic impacts of tobacco; 4) supporting efforts of non-governmental organisations to build advocacy and resources, empower survivors and reduce suffering in low- to middle-income countries by working with governments, medical professionals and the corporate sector to enable individuals to adopt healthier behaviours; 5) promoting culturally-sensitive risk reduction and education campaigns by leveraging US efforts to help build capacity of non-governmental organisations in other countries; and 6) investing in cancer research and expanding access to prevention and early detection measures in the US, with a specific focus on increasing federal funding of medical research.
Matthew Dennis - Editor, Cancer Drug News
Wednesday, December 3, 2008
More teens needed for trials
A new UK study has highlighted the small number of teenagers who are enrolled in clinical trials for cancer, despite the benefits of being involved. Inclusion in studies has been shown to improve cancer survival, because it provides access to new drugs, better quality of care through frequent monitoring and access to a wider group of specialists. The results of the work have been published in the 1st December online edition of the British Journal of Cancer (10.1038/sj.bjc.6604751).
Scientists from University College London analysed enrolment in Phase III trials from April 2005 to March 2007 involving teenagers and young adults (TYA), as well as children. All of the young patients involved in trials had been diagnosed with leukaemia, lymphoma, brain and central nervous system, bone sarcomas or male germ cell tumours. The researchers found that only 25.2 per cent of 15 to 19-year-olds and 13.1 per cent of 20 to 24-year-olds were enrolled in clinical trials, compared with 43.2 per cent of ten to 14-year-olds. Rates increased among ten to 14-year-olds and 15 to 19-year-olds during April 2006 to March 2007 compared with the previous 12 months, but fell among 20 to 24-year-olds.
The investigators noted that there were four trials available for patients with CNS tumours, yet no over-16s were enrolled in these trials. They also observed that over-15s were much less likely to take part in clinical trials in England than children and younger teenagers. The variations in open trials, trial age eligibility criteria and extent of trial activation in treatment centres in part explain this observation. However, other possible influences, such as difficulties associated with the consent of TYA require further evaluation.
Study leader Dr Lorna Fern, who co-ordinates research into TYA with cancer at the National Cancer Research Institute has said that the US and Australia had also reported a similar trend. Young people are constantly falling through the gap between paediatric and adult cancer specialists and there are not enough trials for the types of cancers that affect them. This is an important study that can be used as the base on which progress is measured in the UK. Before now, it was not known how many young people with cancer were recruited onto clinical trials. It is hoped that in the future, closer dialogue between those involved in planning and running trials for children and for adults will improve trial availability and recruitment.
Amending the age eligibility criteria is one possible solution, although it may not completely address the problem of recruiting TYA. In the EURAMOS-1 trial (an international osteosarcoma trial), a fall off in recruitment has been seen beyond the age of 15, despite an age eligibility criteria which spans the whole paediatric and TYA population. Average accrual to EURAMOS-1 in England, Scotland and Wales has demonstrated a decline in accrual from 42.7 per cent for patients aged ten to 14 years, 38.3 per cent for those aged 15 to 19, and 15.7 per cent of patients aged 20 to 24 from 2005 to 2008.
It is feared that significant improvements in outcomes from cancer for TYA will remain elusive without a coalition of forces including funders, policy makers, biologists, clinicians and patients.
Matthew Dennis - Editor, Cancer Drug News
Scientists from University College London analysed enrolment in Phase III trials from April 2005 to March 2007 involving teenagers and young adults (TYA), as well as children. All of the young patients involved in trials had been diagnosed with leukaemia, lymphoma, brain and central nervous system, bone sarcomas or male germ cell tumours. The researchers found that only 25.2 per cent of 15 to 19-year-olds and 13.1 per cent of 20 to 24-year-olds were enrolled in clinical trials, compared with 43.2 per cent of ten to 14-year-olds. Rates increased among ten to 14-year-olds and 15 to 19-year-olds during April 2006 to March 2007 compared with the previous 12 months, but fell among 20 to 24-year-olds.
The investigators noted that there were four trials available for patients with CNS tumours, yet no over-16s were enrolled in these trials. They also observed that over-15s were much less likely to take part in clinical trials in England than children and younger teenagers. The variations in open trials, trial age eligibility criteria and extent of trial activation in treatment centres in part explain this observation. However, other possible influences, such as difficulties associated with the consent of TYA require further evaluation.
Study leader Dr Lorna Fern, who co-ordinates research into TYA with cancer at the National Cancer Research Institute has said that the US and Australia had also reported a similar trend. Young people are constantly falling through the gap between paediatric and adult cancer specialists and there are not enough trials for the types of cancers that affect them. This is an important study that can be used as the base on which progress is measured in the UK. Before now, it was not known how many young people with cancer were recruited onto clinical trials. It is hoped that in the future, closer dialogue between those involved in planning and running trials for children and for adults will improve trial availability and recruitment.
Amending the age eligibility criteria is one possible solution, although it may not completely address the problem of recruiting TYA. In the EURAMOS-1 trial (an international osteosarcoma trial), a fall off in recruitment has been seen beyond the age of 15, despite an age eligibility criteria which spans the whole paediatric and TYA population. Average accrual to EURAMOS-1 in England, Scotland and Wales has demonstrated a decline in accrual from 42.7 per cent for patients aged ten to 14 years, 38.3 per cent for those aged 15 to 19, and 15.7 per cent of patients aged 20 to 24 from 2005 to 2008.
It is feared that significant improvements in outcomes from cancer for TYA will remain elusive without a coalition of forces including funders, policy makers, biologists, clinicians and patients.
Matthew Dennis - Editor, Cancer Drug News
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