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New Study Aims to Rapidly Test Lung Cancer Drugs

New Study Aims to Rapidly Test Lung Cancer Drugs | Lung Cancer Dispatch | Scoop.it

"A bold new way to test cancer drugs started Monday in hundreds of hospitals around the U.S. In a medical version of speed dating, doctors will sort through multiple experimental drugs and match patients to the one most likely to succeed based on each person's unique tumor gene profile.


"It's a first-of-a-kind experiment that brings together five drug companies, the government, private foundations and advocacy groups. The idea came from the federal Food and Drug Administration, which has agreed to consider approving new medicines based on results from the study.


"Its goal is to speed new treatments to market and give seriously ill patients more chances to find something that will help. Instead of being tested for individual genes and trying to qualify for separate clinical trials testing single drugs, patients can enroll in this umbrella study, get full gene testing and have access to many options at once."


Editor's note: Many patients enroll in clinical trials as volunteers to test new drugs they wouldn't otherwise be able to get. But it can be difficult for patients to enroll on clinical trials, and even more difficult to enroll in ones that do a good job of taking into account the specific molecular characteristics of a patients' tumor(s). Other aspects of traditional clinical trials make them inefficient and expensive, and it can take a long time for useful insights to emerge. The study described in this article attempts to overhaul clinical trial design for people with with advanced squamous non-small cell lung cancer (NSCLC). Each patient will have his or her tumor(s) checked for 200 specific mutations. Based on the combination of mutations, his or her oncologist will then be able to request certain experimental drugs for the patient to try. This will hopefully let more patients access their best treatment options faster, and it will allow oncologists to learn more rapidly about the effectiveness of different drugs in different patients.

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The New York Times  |  Jun 16, 2014

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AstraZeneca Seeking to Get Cancer Drugs to Patients Early

AstraZeneca Seeking to Get Cancer Drugs to Patients Early | Lung Cancer Dispatch | Scoop.it

"British patients could benefit from AstraZeneca's promising new cancer drugs well before they complete clinical testing, the Telegraph can reveal.


"Pascal Soriot, chief executive, told the Telegraph he was looking to make two of Astra's most eye-catching cancer drugs widely available to patients as soon as possible.


"Britain's recently launched early access to medicines scheme, which aims to get drugs to patients years earlier than the normal regulatory process allows, is among the programmes in Mr Soriot's sights. The US, France and Japan have also established pathways to fast-track promising new drugs to patients ahead of final regulatory approval."

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The Telegraph  |  Jun 2, 2014

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ASCO: Zykadia Works Before or After Targeted Lung Ca Tx

ASCO: Zykadia Works Before or After Targeted Lung Ca Tx | Lung Cancer Dispatch | Scoop.it

Ceritinib (Zykadia) produced good response in non-small cell lung cancer (NSCLC) overexpressing ALK, regardless of prior treatment for that target, an early phase trial showed.


Ceritinib was associated with an overall response rate of 55% in patients previously treated with crizotinib (Xalkori) and 66% in those naive to that ALK inhibitor, Dong-Wan Kim, MD, of the Seoul National University Hospital, and colleagues found.

Editor's note: This article is about a drug called ceritinib (brand name Zykadia), which was recently approved by the U.S. Food and Dug Administration (FDA), allowing doctors in the U.S. to prescribe it to patients who 1) have advanced non-small cell lung cancer (NSCLC), 2) have tumor cells with mutations in the ALK gene, as detected by molecular testing, and 3) have tried treatment with crizotinib (Xalkori) but experienced worsening of their cancer. According to the new research described in this article, ceritinib may actually be beneficial whether or not the patient was previously treated with crizotinib.
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MedPage Today  |  Jun 3, 2014

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Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686
for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer
(NSCLC) in Patients with the T790M Mutation

Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686 <br/>      for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer <br/>      (NSCLC) in Patients with the T790M Mutation | Lung Cancer Dispatch | Scoop.it

"Clovis Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation. The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M."


Editor's note: CO-1686 is a targeted therapy drug that is meant to treat patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Some tumors with EGFR mutations become resistant to first-line treatment and develop a new mutation called T790M. Evidence shows that non-small cell lung cancer (NSCLC) patients with T790M may benefit from second-line treatment with CO-1686.The drug has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This means that the FDA finds CO-1686 to be very promising compared to currently available treatments for T790M-mutated NSCLC, and will accelerate the approval process that would ultimately permit oncologists to prescribe the drug outside of a clinical trial.

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MarketWatch  |  May 19, 2014

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GW Pharmaceuticals Announces That Sativex Receives Fast Track Designation From FDA in Cancer Pain

"Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Sativex® for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. Sativex is currently in Phase 3 clinical trials for this indication.


"FDA's Fast Track program facilitates the development of drugs intended to treat serious or life‑threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval."

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Nasdaq  |  Apr 28, 2014

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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.

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ScienceDaily  |  Feb 12, 2014

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ScienceDaily  |  Feb 12, 2014

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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.

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Scientific American  |  Nov 26, 2013

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Scientific American  |  Nov 26, 2013

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Scientific American  |  Nov 26, 2013

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FDA to Regulate Personalized Medicine

Now that medical treatment is increasingly tailored to patient subtypes (eg, lung cancer patients with mutations in the ALK gene can be treated with Xalkori), the U.S. Food and Drug Administration (FDA) has released a new report explaining how it will regulate personalized therapies and tests. The first targeted therapy used in the U.S. was trastuzumab, which is for HER2 breast cancer and was approved in 1998. Since then, the FDA has approved more than 100 treatments that target specific genetic abnormalities, including four drugs for cancer subtypes that are identified by companion test kits.

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Medscape│Oct 29, 2013

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Roche Gets Breakthrough Status for Lung Cancer Drug

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a lung cancer treatment  called alectinib, made by Roche. The designation was based on new data presented at the European Cancer Congress (ECC).  Alectinib is reported to be effective in patients with non-small cell lung cancer (NSCLC) with mutations in the ALK gene. Imporantly, tumor shrinkage was seen in patients whose cancer worsened on crizotinib (Xalkori), the currently approved drug for this subgroup of patents.

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Drug Discovery and Development | Sep 23, 2013

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FDA Puts Lung Cancer Drug Ganetespib on Fast Track

FDA Puts Lung Cancer Drug Ganetespib on Fast Track | Lung Cancer Dispatch | Scoop.it

Ganetespib, a potential new treatment for non-small cell lung cancer (NSCLC), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). Fast Track status, reserved for drugs aimed at serious conditions with unmet treatment needs, provides for closer FDA guidance during the drug development process and quicker review for approval. Two clinical trials, GALAXY-1 and GALAXY-2, are currently examining the use of ganetespib in combination with the chemotherapy agent Taxotere (docetaxel) for treating advanced lung adenocarcinoma, a type of NSCLC. Ganetespib acts by blocking Hsp90, a protein that facilitates several components of tumor development and spread.

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MarketWatch | Sep 12, 2013

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FDA Approves Afatinib/Gilotrif for Lung Cancer Treatment

Based on the positive results of a recent clinical trial, the FDA approved afatinib for first-line treatment of patients with late-stage, non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. The drug, which will be marketed under the name Gilotrif, is specifically intended for patients with two particular EGFR mutations: exon 19 deletion and exon 21 L858R substitution. The FDA also approved the therascreen EGFR RGQ PCR Kit, a companion diagnostic used to test for EGFR mutations. Afatinib differs from other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa) in that it irreversibly destroys the EGFR protein, instead of just reversibly blocking it, and also inhibits several other related proteins.

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Food and Drug Administration (FDA) | July 12, 2013

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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.

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New York Times | Jul 7, 2013

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New York Times | Jul 7, 2013

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New York Times | Jul 7, 2013

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Cancer Drug Shortages in the U.S. Are Harmful and Costly

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year, and 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase healthcare costs by driving up drug prices and tying up health care provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report at: http://www.ajhp.org/content/70/7/609.abstract

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ScienceDaily | Mar 21, 2013

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New Laws Give Dying Patients ‘Right to Try’ Unproven Drugs

New Laws Give Dying Patients ‘Right to Try’ Unproven Drugs | Lung Cancer Dispatch | Scoop.it

"Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try.


"Lawmakers in the three states have passed “Right to Try” laws with unanimous votes in recent weeks, after high-profile, social media campaigns in which families of dying patients have pushed for access to unapproved but potentially lifesaving drugs. Colorado’s governor is expected to sign that state’s law Saturday."


Editor's note: New cancer drugs can take a long time to reach the clinic, even after they have already proven safe and beneficial. Some patients are successful in gaining early access to drugs (see our Chief Scientist's blog post on so-called "compassionate access"), but it is a difficult process. Some drug companies are trying to remedy the issue by starting "expanded access trials" that give drugs to patients unable to enroll in the clinical trials testing them. For example, Novartis made its promising drug LDK378 available under expanded access in trial number NCT01947608 in September, 2013.

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The Washington Post  |  May 16, 2014

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The Washington Post  |  May 16, 2014

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The Washington Post  |  May 16, 2014

Tambre Leighn's curator insight, June 5, 2014 11:12 AM

Let's see more states get behind this kind of legislation.  Cancer survivors and their loved ones have enough challenges and stressed to cope with - fighting for the right to try every option available should not be one of them.

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Cyramza Yields a Modest Survival Benefit in Second-line NSCLC

"Cyramza™ (ramucirumab, IMC-1121B; Eli Lilly) is a human IgG1 monoclonal antibody directed against the extracellular domain of VEGFR-2. It was recently approved by the Food and Drug Administration (FDA) for advanced gastric cancer or gastroesophageal junction adenocarcinoma. On February 19, 2014, Lilly announced via press release that the REVEL trial was positive for both overall survival (OS) and progression-free survival (PFS) benefit. Results from the randomized, double-blind, placebo-controlled Phase III REVEL trial (NCT01168973) were reported at the 2014 annual meeting of the American Society of Clinical Oncology (ASCO). The trial evaluated docetaxel with or without Cyramza in squamous or non-squamous Stage IV non-small cell lung cancer (NSCLC) patients following disease progression after one prior platinum-based therapy."


Editor's note: A new targeted drug called Cyramza (aka ramucirumab) shows promise as a potential treatment for people with advanced non-small cell lung cancer (NSCLC). In a clinical trial, scientists tested the drug on volunteer patients with stage IV NSCLC. Compared to standard chemotherapy alone, patients who were treated with chemo plus Cyramza lived longer and had more time pass before their cancer worsened.

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OBR  |  Jun 3, 2014

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FDA Grants Merck’s Anti-PD1 Antibody Priority Review

FDA Grants Merck’s Anti-PD1 Antibody Priority Review | Lung Cancer Dispatch | Scoop.it

"The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months."


Editor's note: MK-3475 is an immunotherapy drug that works by boosting a patient's own immune system to fight cancer. While this story is about melanoma, anti-PD1 drugs like MK-3475 have also shown promise for other cancers, including for lung cancer. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system. 

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Cancer Network  |  May 21, 2014

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FDA Approves Ceritinib (Zykadia) for Metastatic Lung Cancer

FDA Approves Ceritinib (Zykadia) for Metastatic Lung Cancer | Lung Cancer Dispatch | Scoop.it

"Earlier today the US Food and Drug Administration granted accelerated approval to ceritinib (Zykadia) for the treatment of patients with metastatic ALK-positive non–small-cell lung cancer (NSCLC). About 2% to 7% percent of NSCLC patients have ALK-positive disease.


"The new drug, a tyrosine kinase inhibitor, was approved 4 months early under the FDA's accelerated approval program and is intended for the treatment of patients who previously received the ALK-inhibitor crizotinib."


Editor's note: FDA approval means that doctors can now begin prescribing ceritinib treat patients with advanced non-small cell lung cancer (NSCLC) whose tumors have mutations in the ALK gene, as detected by molecular testing. We previously posted about ceritinib here.

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Cancer Network  |  Apr 29, 2014

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Helix BioPharma Corp. Receives U.S. Food and Drug Administration Approval to Initiate a Clinical Trial of L-DOS47 in Combination With Pemetrexed and Carboplatin

Helix BioPharma Corp. Receives U.S. Food and Drug Administration Approval to Initiate a Clinical Trial of L-DOS47 in Combination With Pemetrexed and Carboplatin | Lung Cancer Dispatch | Scoop.it

"Helix BioPharma Corp. (frankfurt:HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase I clinical trial with L-DOS47.


"The study is entitled "A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer"."


Editor's note: Clinical trials can be a way for some lung cancer patients to access certain treatments they would not otherwise be able to have. Learn more.

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MarketWatch  |  Apr 22, 2014

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Cancer Drug Tafinlar Receives Breakthrough Therapy Designation for Lung Cancer

Cancer Drug Tafinlar Receives Breakthrough Therapy Designation for Lung Cancer | Lung Cancer Dispatch | Scoop.it

The application for dabrafenib (Tafinlar) as a treatment for certain lung cancer cases has been given a boost with the U.S. Food and Drug Administration (FDA) designating it a breakthrough therapy. Tafinlar is being investigated as a therapy for patients with non-small cell lung cancer (NSCLC) who have a mutation called BRAF V600E in the BRAF gene and have received at least one previous round of chemotherapy. In a recent clinical trial, Tafinlar exhibited antitumor activity in such patients. The breakthrough therapy designation provides increased drug development guidance from the FDA and accelerated approval for drugs that treat serious or life-threatening conditions and that provide a substantial improvement over currently available treatments. Tafinlar is already approved for use in certain types of skin cancer.

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ASCO Post  |  Jan 13, 2014

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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.

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ASCO Post  |  Nov 21, 2013

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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.

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New York Times | Oct 31, 2013

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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.

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Reuters | Sep 26, 2013

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Despite FDA Act, Cancer Drug Trial Results Often Not Published

Despite FDA Act, Cancer Drug Trial Results Often Not Published | Lung Cancer Dispatch | Scoop.it

Passed in 2007, the U.S. Food and Drug Administration Amendments Act included a provision requiring the publishing of all clinical trials for cancer drugs performed in the U.S. However, an examination of online public records and journals revealed that nearly half of phase II, phase III, and phase IV clinical trial data have not been made available to the public. The researchers found 646 clinical trials in an online registry with completion dates between December 26, 2007 and May 31, 2010. But 1 year after completion, just 9% of clinical trial results had been posted at ClinicalTrials.gov, and only 12% had been posted in online journals (20% total availability). Three years after completion, 31% of clinical trial data had been posted on ClinicalTrials.gov and 35% had been posted in journals, with 55% available via both sources. The researchers called for better reporting of clinical trial data, as it could have an impact on patient treatment and safety.

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Medical Xpress | Jul 23, 2013

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Afatinib May Be Candidate for First-Line Treatment in Certain Lung Cancers

Results from the LUX-Lung 3 clinical trial show that afatinib appears to be well tolerated and more effective than chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Afatinib produced higher response rates and longer periods without cancer progression than cisplatin (Platinol) plus pemetrexed (Alimta), suggesting that it could be considered as a first-line therapy in advanced EGFR-mutant NSCLC. Afatinib, which is under priority review for approval by the FDA, may be effective in patients resistant to other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa). However, no trials so far have directly compared afatinib with Tarceva or Iressa.

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Medscape | Jul 9, 2013

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FDA Approves Expanded Use and Companion Diagnostic for Tarceva

The FDA has approved the use of erlotinib (Tarceva) as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Tarceva, a tyrosine kinase inhibitor (TKI) that inhibits EGFR, had already been approved for patients with advanced NSCLC as a second- or later-line treatment if at least one chemotherapy regimen had failed, or as maintenance treatment if their disease had not progressed after four cycles of chemotherapy. At the same time, the FDA approved, for the first time, a test for EGFR mutations, the cobas EGFR Mutation test. The test enables doctors to identify which patients have EGFR mutations and are therefore candidates for first-line treatment with Tarceva, making it a so-called 'companion diagnostic' for Tarceva.

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ASCO Post | May 14, 2013

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