Category Archives: Cancer

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An FDA advisory panel has declared that the agency should require companies seeking accelerated approval for cancer drugs to submit at least one controlled trial to bolster their case. More than half of the drugs approved through the agency’s expedited pathway have been okayed on the basis of a single-arm trial. The Oncologic Drugs Advisory Committee met specifically to discuss ways to improve the accelerated approval pathway for cancer drugs. A 1992 law, passed with the intention of speeding up the approval process for drugs that treat serious diseases, allows the FDA to approve drugs that “meet an unmet medical need” based on surrogate endpoints. However, the FDA’s accelerated approval is contingent on post-marketing trials that verify the surrogate endpoints did actually prove that the drug is safe and effective. Earlier in the week , the panel and FDA officials questioned representatives of six drug companies about their failure to complete follow-up studies that were part of the deal by which they received accelerated approval.

The six companies grilled on the progress of their post-marketing studies were:

1. Elli Lilly, for cetuximab (Erbitux)

2. GlaxoSmithKline, tositumomab and iodine (Bexxar) and nelarabine (Arranon)

3. Genzyme, clofarabine (Clolar)

4. Amgen, panitumumab (Vectibix)

5. Novartis, imatinib mesylate tablets (Gleevec)

Although the FDA has the authority to fine a company or to revoke a drug’s approval if its maker fails to present evidence that the drug works, no such threats were made.

“Doublet chemotherapy improved survival in elderly patients with lung cancer, compared with single-agent chemotherapy; the combination of carboplatin and paclitaxel proved better than single-agent gemcitabine or vinorelbine.

Best-ever survival rates in metastatic pancreatic cancer were reported with chemotherapy combination. In this phase 3 trial, the combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) bested the standard single-agent therapy, gemcitabine (Gemzar).
Bevacizumab (Avastin) extended progression-free survival in advanced ovarian cancer; the biologic was added to standard chemotherapy with carboplatin and paclitaxel.
Ipilimumab improved survival in advanced melanoma, the first time that a survival benefit has been shown in a phase 3 trial in advanced melanoma. The drug is a monoclonal antibody that keeps T cells activated, and is currently awaiting approval.
Hypofractionated radiotherapy for early-stage breast cancer, comprising a shorter 3-week course of a higher dose of radiation, was just as effective as the standard 5-week course (N Engl J Med. 2010;362:513-520).
Crizotinib, a specific ALK inhibitor, produced dramatic response rates in a phase 1 trial in patients with lung cancer and the ALK mutation (found in about 20% of patients); more than two thirds of patients showed tumor shrinkage.
PLX4032, which targets BRAF, showed very high response rates in patients with advanced melanoma and the BRAF mutation (found in about 50% of patients).
Palliative care added to chemotherapy in lung cancer patients significantly improved survival (N Engl J Med. 2010;363:733-742). This study was described as “”paradigm shifting”” in an editorial that accompanied the study (N Engl J Med. 2010;363:781-782).
In the first large study to evaluate insomnia in patients undergoing chemotherapy, sleep problems were found to affect more than three quarters of these patients, which is nearly 3 times the rate found in the general population (J Clin Oncol. 2009;28:292-298).
The cancer vaccine sipuleucel-T (Provenge) was approved for metastatic hormone-refractory prostate cancer; it is the first immunotherapeutic for this disease.
New chemotherapy for prostate cancer — cabazitaxel (Jevtana) — was approved for use in advanced hormone-refractory prostate cancer in patients who had failed on docetaxel.”

“The uptake of new cancer drugs in the United Kingdom lags behind that of many other countries, mostly because reimbursement is refused on grounds of cost-effectiveness. It is an issue that is regularly highlighted in the media, often with emotive case histories of cancer patients who are refused access to potentially life-saving medicines.
In an effort to counter this problem head-on, the new coalition government has set up a new Cancer Drug Fund that will pay for medicines that the National Institute of Clinical Excellence has not allowed for use in the National Health System.
This fund was to start up on April 2011, and was pledged to be worth £200 million, but the start-up date has just been brought forward to October 2010, and an extra £50 million has been allocated to cover the initial 6 months of operation.
The announcement of this new “”emergency fund”” was made at the launch of a new government report showing the extent to which the uptake of new cancer drugs in the United Kingdom lags behind that of other countries.”

”The All Indian Origin Chemists and Distributors (AIOCD) Ltd, the distribution and retail company of the All India Organisation of Chemists and Druggists (AIOCD) which has forayed into sales of its own generic brands recently, is planning to set up an oncology division within next four months to launch and market generic cancer drugs in the market. After completing works to launch more than 100 generic brands in antibiotic, gastroenteritis, analgesics and multivitamin segments by the end of this month, the company has identified therapeutic segment of oncology as the next target area for its future expansion and operation. The new division is expected to be launched by the month of November this year. ”

”Pharma MNCs Eye India for off-shoring CRO allied services
‘Allied services market in India is growing at 21% compared to 7.5% globally’

Not just for clinical trials, but India is also emerging as an attractive destination for allied services related to clinical research. According to a recent FICCI- Ernst & Young study, the Indian allied service market is growing at a compounded growth rate of 21 per cent as compared to 7.5 per cent globally.
The allied services outsourced market in India was estimated to be $106 million in 2008 and is growing at a rate of 21 per cent. These services comprise bio-statistics, data management, pharma co-vigilance and together they account for around 35 per cent of total global clinical research spend. The size is estimated to be around $22 billion globally. The global clinical research industry is currently pegged at $64 billion.

There are more than 40 companies in India which offer one or more allied services. According to Apurva Shah, group managing director, Veeda Clinical Research, “”While outsourcing to India started for cost arbitrage in late 1990s, most western sponsors have now realised that Indian CROs can contribute a lot more. Indian CROs have graduated from just doing simple studies to doing more complex and challenging studies. We no longer just execute protocols but contribute in several ways to add value to the sponsor’s drug development””. The likes of Pfizer, Eli Lilly, Astrazeneca, GlaxoSmithKline, Bayer get allied services work done here in India.
With the rise of clinical trial sites outside the US and Europe, and tightening of regulatory requirements that require thorough documentation and audit trials, India with its track record of managing IT-ITeS work has emerged as a favoured destination for outsourcing allied services work.
Columbus headquartered Veeda Oncology, a full service Oncology clinical research organisation (CRO) with facilities in North America, Europe and India, plans to conduct the bulk of the recent $8.4 million of new clinical research programs it has been awarded in the last one month in India itself.
Shah said, “”India’s share of revenue has risen from 20 per cent in 2006 to 60 per cent in our present global revenue. We expect a steady growth to continue due to the attractiveness of India in terms of the value proposition. It’s the combination of quality, speed and cost. It’s the “can do” attitude and hard work that’s wining the work””.
The cost of a data entry operator here is around $10-20 per hour, compared to $30-50 per hour in developed economies, says the report. Similarly, a bio-statistician and a medical writing professional charges around $30-70 per hour in India compared to $100-150 in western countries.
The world’s fifth largest clinical research organization (CRO) and Nasdaq listed Kendle that started operations at Mindspace, a special economic zone near Ahmedabad, plans to have a data center here that will serve as a back-end operation for data management, pharmacovigilence, bio-statistics, analytical work, medical writing and support of clinical research.”

After the “”Blockbuster”” approval of the prostrate cancer vaccine, Provenge, the FDA has decided to carry out ”surveillance”” studies on almost all medications used to treat prostrate cancer in men.
Medications primarily used to treat men with prostate cancer, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men treated with one of the medications. The proof of this is a screen shot from the website which to the surprise of many. Its indeed amazing that the FDA within 2 days of its approval of the novel prostate cancer vaccine has now decided to “”dictate”” safety terms on existing drugs used to treat prostrate cancer.

World cancer Summit in 2008 was marked with the Following:

Cancer prevention and early detection Increase efforts to reduce tobacco consumption by encouraging governments to fully implement and enforce the FCTC (WHO Framework Convention on Tobacco Control) Raise awareness about the need for culturally sensitive cancer risk reduction campaigns, along with public and professional education about cancer warning signs. Push governments to implement policies that will support risk-reducing strategies at a community level and enable individuals to make more informed consumption choices and adopt healthier behavior Encourage governments to implement measures to reduce people’s exposure to environmental and occupational carcinogens Undertake actions to ensure that vaccines and other strategies that are shown to prevent cancer-causing infections are made more widely available Advocate for the provision of affordable screening programmes for which there is evidence of efficacy in the population in question. Undertake pilot projects that are designed to evaluate the feasibility and efficacy in populations in which the screening technology has not yet been tested.

Cancer treatment Promote the development and use of cancer treatment guidelines that are relevant to local needs and resources. Ensure that sufficient treatment, rehabilitation and palliative care facilities and well-trained staff are available to meet the physical, social and emotional needs of patients with cancer Take steps to tackle the many barriers to optimal pain control. Work with governments to address the over-regulation of pain medicines.Cooperate with international organizations, including the International Narcotics Control Board and the World Health Organization, to ensure that global implementation of the UN’s international drug control conventions do not unduly interfere with legitimate efforts to advance access to pain medicines for cancer patients in pain Work with the pharmaceutical industry to increase access to cancer medicines that are affordable and of assured quality Increase the number of health professionals with expertise in all aspects of cancer control by providing specialist training opportunities and fellowships to enable professionals to study in specialist settings Raise awareness about the impact of health worker emigration on the ability of countries to provide adequate levels of cancer care and work collectively to address global and national health workforce shortages and the resultant deepening of inequity Increase investment in independent basic and applied cancer research and accelerate the translation of research findings into clinical and public health practice Encourage cancer research organizations in different countries to collaborate, share data and define complementary research objectives to optimize the use of the limited funds available for cancer research and reduce duplication of effort .

“Most New Cancer Cases and Deaths Occur in Developing World
Worldwide estimates of the numbers of new cases of and deaths from cancer are now available online in one place — GLOBOCAN 2008. The Internet-based resource is a project of the International Agency for Research on Cancer (IARC) in Lyon, France.
The database, which uses statistics from 2008, provides information on the burden of cancer overall and for 27 specific cancer types for almost all countries and regions of the world.
It also reveals that most new cancer cases (56%) and deaths (63%) occur in less developed regions of the world, such as Asia and South America.
The most common cancers worldwide are lung (1.61 million, 12.7% of the total), breast (1.38 million, 10.9%), and colorectal (1.23 million, 9.7%). The most common causes of cancer death are lung (1.38 million, 18.2% of the total), stomach (0.74 million, 9.7%), and liver (0.69 million, 9.2%) cancers. However, there is not uniformity in the worldwide data in terms of types of cancers and their incidence and mortality.”

“Germany’s Merck KGaA and its U.S. partner Oncothyreon have resumed testing their experimental cancer vaccine on lung-cancer patients, reviving hopes for a key pipeline drug.
The U.S. Food and Drug Administration (FDA) partially lifted the clinical hold it had placed on Stimuvax trials, allowing the drug makers to resume their START and INSPIRE Phase III trials in non-small cell lung cancer. The Phase III STRIDE trial in breast cancer remains suspended, it added. Merck on March 23 suspended testing of its experimental cancer vaccine on humans after a patient contracted encephalitis in another setback at the drugs unit from which it is trying to diversify. [ID:nLDE62M07T] The case of brain inflammation emerged in a mid-stage trial with 30 participants where Stimuvax vaccine was tested against multiple myeloma, a type of cancer affecting the bone marrow and white blood cells. Merck and Oncothyreon are racing with biotech firms including Transgene , Dendreon Corp and Antigenics to bring cancer vaccines to market. Stimuvax, based on an active ingredient known as BLP25, is designed to prime a patient’s immune system against certain cancer cells after a tumour has been diagnosed. “

”Improving cancer survival rates are real success stories that sometime get lost in the noise over our healthcare system. However, “”Targeted drugs are driving that survival in a major way.
Some cancer drugs like Sutent have proven effective for both stomach and kidney cancer and are likely to give benefits in both the cases as per the reports from the late phase clinical trials. Sutent (Pfizer Oncology product) has become one of the more expensive cancer drugs on the market at around $50,000. But even at that price, it’s become key to a treatment approach known as daisy-chaining, in which patients use one drug until it stops working, then move on to another. Some patients have survived as long as seven years this way.
Is paying for that survival sustainable? In Sutent’s case at least, even the U.K.’s cost watchdog thinks so; the National Institute for Health and Clinical Excellence finally OK’d the drug after Pfizer agreed to pay for the first cycle of treatment, which should weed out the patients who just won’t respond to the drug at all”