Lung Cancer Dispatch
Follow
Find tag "regulation"
3.6K views | +0 today
Lung Cancer Dispatch
News for Patients and Physicians
Curated by Cancer Commons
Your new post is loading...
Your new post is loading...
Suggested by Cancer Commons
Scoop.it!

Development of Diagnostic Tests for Targeted Therapies Faces Multiple Challenges

Targeted therapies are treatments aimed at specific biomarkers, such as genetic mutations, or overexpressed proteins. Tests that detect the targeted biomarker are needed to determine whether a patient would benefit from the treatment. The FDA offers an approval pathway for such tests, so-called “companion diagnostics” (CoDx), which requires that the test be evaluated alongside the drug in clinical trials. However, testing laboratories can also develop their own tests. These “laboratory-developed tests” (LDTs) are not currently regulated by the FDA. Development of LDTs is therefore much cheaper and faster (making CoDx comparatively less economically viable), but provides less evidence that these tests are indeed effective. Moreover, LDTs can be designed to test for many different biomarkers, thus making more efficient use of limited biopsy tissue, while CoDx usually only test for the one biomarker relevant for their companion drug. A recent article calls for test developers, pharmaceutical companies, insurers, and the FDA to collaborate in resolving these issues.

Cancer Commons's insight:

ScienceDaily  |  Feb 12, 2014

more...
Cancer Commons's curator insight, February 20, 11:34 AM

ScienceDaily  |  Feb 12, 2014

Cancer Commons's curator insight, February 20, 11:34 AM

ScienceDaily  |  Feb 12, 2014

Suggested by Cancer Commons
Scoop.it!

FDA Mulls Change in Cancer Drug Approval Process

FDA Mulls Change in Cancer Drug Approval Process | Lung Cancer Dispatch | Scoop.it

Modern cancer research indicates that cancers driven by genetic mutations in the same chemical pathway (a group of proteins in a cell that work together) may be more closely related, even if they occur in different parts of the body, than two cancers driven by different mutations that occur in the same organ. Current U.S. Food and Drug Administration (FDA) standards, however, still use the traditional anatomical location-based categories when approving cancer drugs (eg, lung cancer versus pancreatic cancer). As a result, a drug that is approved for treating a specific cancer caused by a given mutation must undergo new clinical trials to get approved for treating a cancer driven by the same mutation in another body part. However, the FDA’s 'cancer czar' recently floated an unofficial proposal for approving cancer drugs based on the chemical pathways they target. Such a change could greatly streamline cancer drug development.

Cancer Commons's insight:

Scientific American  |  Nov 26, 2013

more...
Cancer Commons's curator insight, December 3, 2013 3:27 PM

Scientific American  |  Nov 26, 2013

Cancer Commons's curator insight, December 3, 2013 3:27 PM

Scientific American  |  Nov 26, 2013

Suggested by Cancer Commons
Scoop.it!

Compassionate Use of Unapproved Drugs Raises Difficult Ethical Issues

Compassionate Use of Unapproved Drugs Raises Difficult Ethical Issues | Lung Cancer Dispatch | Scoop.it

Patients with terminal illnesses, including late-stage cancer patients, are understandably eager to try still-unapproved experimental drugs once other options have been exhausted. The U.S. Food and Drug Administration (FDA) recently created a program to make it easier for drug companies to grant 'compassionate use,' which allows patients in extraordinary need access to otherwise unauthorized treatments. However, the decision to dispense experimental drugs is left to the companies, which are often reluctant to take this risky step. Experimental drugs are just that–experimental; they may have catastrophic side effects or simply not work. When these drugs are given outside the framework of a well-designed clinical trial, it becomes impossible to judge decisively whether they actually work. And if all patients could bypass clinical trials, there would be no incentive for anyone to enroll in these clinical trials, meaning that new drugs would never be properly studied and approved. Compassionate use therefore needs to be approved by experienced medical professionals on a case-by-case basis, and remain an option of last resort only.

Cancer Commons's insight:

New York Times | Oct 31, 2013

more...
Cancer Commons's curator insight, November 1, 2013 11:51 AM

New York Times | Oct 31, 2013

Cancer Commons's curator insight, November 1, 2013 11:51 AM

New York Times | Oct 31, 2013

Suggested by Cancer Commons
Scoop.it!

Requirement for Randomized Clinical Trials May Be Reduced for Some New Cancer Drugs

Requirement for Randomized Clinical Trials May Be Reduced for Some New Cancer Drugs | Lung Cancer Dispatch | Scoop.it

To gain regulatory approval, new drugs must complete randomized clinical trials involving large numbers of patients. In these trials, some participants receive the drug, while others receive a standard treatment for the disease, to assess whether the new drug is truly superior to existing treatments. However, in cases where preliminary data strongly suggest that a new drug is more effective than standard treatments, such as with targeted cancer therapies, some experts argue that large, randomized trials are ethically indefensible, because they mandate that many patients receive treatment that is likely inferior. In the U.S., a new 'breakthrough therapy' pathway has been created for such drugs, which greatly reduces the requirement for large, randomized clinical trials and speeds up the approval process.

Cancer Commons's insight:

Reuters | Sep 26, 2013

more...
No comment yet.
Suggested by Cancer Commons
Scoop.it!

Laboratory-Developed Tests Need to Be Better Regulated

Diagnostic medical tests, including those used to detect cancers, usually have to be examined by the FDA for safety and accuracy before getting approved. However, tests created by clinical laboratories (so-called laboratory-developed tests or LDTs) are exempt from this requirement. Such tests were originally intended for internal and research use only. However, with the rise of commercial laboratory testing companies, LDTs are reaching the general patient population. Because these tests have not been proven to deliver accurate and meaningful results, they could potentially mislead and harm patients. The FDA has drawn up a draft guidance document outlining better regulation for LDTs, but it is currently stalled in committee.

Cancer Commons's insight:

New York Times | Jul 7, 2013

more...
Cancer Commons's curator insight, July 11, 2013 3:44 PM

New York Times | Jul 7, 2013

Cancer Commons's curator insight, July 11, 2013 3:44 PM

New York Times | Jul 7, 2013

Cancer Commons's curator insight, July 11, 2013 3:44 PM

New York Times | Jul 7, 2013

Suggested by Cancer Commons
Scoop.it!

Taking Steps to Reduce Rates of Silica-Related Lung Cancer

Taking Steps to Reduce Rates of Silica-Related Lung Cancer | Lung Cancer Dispatch | Scoop.it

Silica is a chemical found in sand and quartz and used in a multitude of industrial applications. Inhalation of silica dust can occur in a number of occupations and increases the risk of lung cancer. A recent review highlights new developments in understanding the health effects of silica exposure and recommends steps to reduce silica-related illness and death. Studies documenting the health risks associated with different levels of silica exposure have enabled evidence-driven regulations. Federal regulators are considering lowering the permissible occupational exposure to silica for workers, a measure that could cut the number of silica-related deaths in half. The review authors also recommend that workers exposed to silica who also smoke undergo computed tomography (CT) scans to screen for lung cancer starting at age 50 years.

Cancer Commons's insight:

Medical News Today  |  Dec 12, 2013

more...
No comment yet.
Suggested by Cancer Commons
Scoop.it!

FDA Grants Regular Approval to Xalkori for Treatment of ALK-Mutant Lung Cancer

FDA Grants Regular Approval to Xalkori for Treatment of ALK-Mutant Lung Cancer | Lung Cancer Dispatch | Scoop.it

The U.S Food and Drug Administration (FDA) has granted regular approval to the drug crizotinib (Xalkori) for the treatment of advanced non-small cell lung cancer (NSCLC) in patients who have mutations in the ALK gene. Xalkori received accelerated approval for this application in August 2011. Regular approval was awarded based on the results of a study examining patients with advanced NSCLC whose cancer had progressed despite first-line chemotherapy. Patients treated with Xalkori went an average of 7.7 months without further cancer worsening, compared to 3.0 months in those receiving the chemotherapy agents pemetrexed (Alimta) or docetaxel (Taxotere). Tumors shrank in 65% of the Xalkori-treated patients, compared to 20% with Alimta or Taxotere. However, overall survival did not differ between the Xalkori group and the chemotherapy group.

Cancer Commons's insight:

ASCO Post  |  Nov 21, 2013

more...
No comment yet.
Suggested by Cancer Commons
Scoop.it!

Sharing Clinical Trial Data: Benefits and Concerns

Sharing Clinical Trial Data: Benefits and Concerns | Lung Cancer Dispatch | Scoop.it

Policymakers and regulatory agencies are increasingly pushing for more public access to clinical trial information. Requiring clinical trial sponsors to be more transparent about their findings would provide greater accountability and discourage unethical trial practices, suppression or selective reporting of results, or misleading analyses. Data sharing would also prevent unnecessary duplication of studies. However, disclosing clinical trial data also risks compromising the privacy of trial participants. Moreover, making a sponsor’s trial data freely available could give unfair advantages to competitors, who could potentially use the data without incurring the cost of producing it. This may discourage companies from performing trials altogether. Clinical trial data sharing therefore needs to incorporate reasonable safeguards for participant privacy and companies’ intellectual property.

Cancer Commons's insight:

New England Journal of Medicine | Oct 21, 2013

more...
Cancer Commons's curator insight, October 30, 2013 12:58 PM

New England Journal of Medicine | Oct 21, 2013

Cancer Commons's curator insight, October 30, 2013 12:58 PM

New England Journal of Medicine | Oct 21, 2013

Suggested by Cancer Commons
Scoop.it!

Should Clinical Trial Requirements Be Relaxed for Certain Cancer Drugs?

Should Clinical Trial Requirements Be Relaxed for Certain Cancer Drugs? | Lung Cancer Dispatch | Scoop.it

Broadly speaking, clinical trials are designed to demonstrate that a drug is safe (phase I), effective (phase II), and better than existing treatments (phase III). However, some drugs already show strong signs of superior effectiveness in phase I and II. A recent article argues for waiving the phase III trial requirement for such drugs, particularly for targeted cancer treatments directed at specific genetic mutations. This would save the enormous costs of these trials and avoid the possibility of the control groups in such trials possibly receiving less effective treatments. On the other hand, eliminating phase III trials would mean that a drug’s long-term effects would not be systematically investigated.

Cancer Commons's insight:

Medical News Today | Aug 12, 2013

more...
Cancer Commons's curator insight, August 13, 2013 10:45 AM

Medical News Today | Aug 12, 2013

Cancer Commons's curator insight, August 13, 2013 10:45 AM

Medical News Today | Aug 12, 2013

Cancer Commons's curator insight, August 13, 2013 10:45 AM

Medical News Today | Aug 12, 2013