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

New Laws Give Dying Patients ‘Right to Try’ Unproven Drugs | Melanoma 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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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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Nasdaq  |  Apr 28, 2014

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Nasdaq  |  Apr 28, 2014

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New Treatments for Advanced Melanoma Presented at AAD

New Treatments for Advanced Melanoma Presented at AAD | Melanoma Dispatch | Scoop.it

"In recent years, the FDA has approved new drugs for the treatment of advanced melanoma, which has presented new ways to treat the disease, according to a presentation at the American Academy of Dermatology annual meeting.


“ 'In the last four years there have been four new drugs that have been FDA-approved for melanoma and what’s even more exciting is that they really speak to two new ways to treating melanoma,' Allan C. Halpern, MD, MSc, chief of dermatology service at Memorial Sloan-Kettering Cancer Center, told Healio.com.


"The most recent FDA approval, in January, was the combination of a BRAF inhibitor and a MEK inhibitor for treating advanced melanoma."

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Healio  |  Mar 23, 2014

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Trial Supports Recent US FDA Approval of New Melanoma Combo Treatment

Trial Supports Recent US FDA Approval of New Melanoma Combo Treatment | Melanoma Dispatch | Scoop.it

The US Food and Drug Administration just granted accelerated approval for a treatment that combines two drugs that target melanomas with BRAF mutations — but this was contingent results of an ongoing phase III clinical trial. The drugs are the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist). Now the latest results of the trial are in and they look good. This combination treatment is not approved elsewhere in the world, and the trial included 423 people from Australia, Europe, and North and South America. Final results are expected later this year and will be presented at a scientific meeting. In addition, another trial is comparing this combination treatment to the BRAF inhibitor vemurafenib (Zelboraf), which is also FDA-approved.

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GlaxoSmithKline │ Jan 24, 2014

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FDA OKs Trial of Stem Cell Therapy for Melanoma

A promising stem cell-based immunotherapy against melanomas has been fast-tracked by the U.S. Food and Drug Administration (FDA), based on previous clinical trials showing that it may double 5-year survival rates to about 50%. The upcoming phase III clinical trial will accept 250 people with melanomas that have spread; enrollment is expected to begin in early 2014. This experimental immunotherapy uses a mixture of a person's own cells: cancer stem cells from his or her tumor, which are thought to be behind the spread of tumors, and immune system cells from the blood, which learn to recognize the cancer stem cells. These cancer stem cells are inactivated to keep them from forming new tumors,  then the mixture is injected back into the patient. The reintroduced immune system cells then focus an attack on the cancer stem cells that remain in the tumor, which helps keep them from spreading.

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California Stem Cell, Inc.│Dec 3, 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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Medscape│Oct 29, 2013

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Medscape│Oct 29, 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 | Melanoma Dispatch | Scoop.it

Passed in 2007, the U.S. Food and Drug Administration (FDA) 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 one 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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Medical Xpress | Jul 23, 2013

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Medical Xpress | Jul 23, 2013

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FDA Asked to Approve New Combination Treatment for Melanoma

FDA Asked to Approve New Combination Treatment for Melanoma | Melanoma Dispatch | Scoop.it

Two new drugs that target melanomas were just approved by the U.S. Food and Drug Administration (FDA) in May, and the drug developer has already filed for approval to use them in combination. The drugs are dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), a MEK inhibitor, and both are made by GlaxoSmithKline. The combination treatment request is based on promising results of a phase I/II trial, which showed that the two drugs work better together than dabrafenib does alone. Results of a phase III trial of the combination therapy are expected later this year.

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PharmaTimes│Jul 9, 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; 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 health care 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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ScienceDaily | Mar 21, 2013

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FDA Grants Merck’s Anti-PD1 Antibody Priority Review

FDA Grants Merck’s Anti-PD1 Antibody Priority Review | Melanoma 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. 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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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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Induction of Systemic Immunity Following Treatment of Tumors with PV-10 Reported by Moffitt Cancer Center Researchers at American Association for Cancer Research Annual Meeting

"Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that a poster presentation detailing significant decrease in melanoma cells in patients' injected tumors 7-14 days after intralesional PV-10 treatment that was accompanied by similar decrease in uninjected bystander tumors was presented April 6 by researchers from the Moffitt Cancer Center at the American Association for Cancer Research Annual Meeting in San Diego, CA. These clinical and pathologic changes were accompanied by increases in important immune cell populations detected in the patients' peripheral blood."


Editor's note: This story is about a new treatment called PV-10 that is injected directly into melanoma tumors. A clinical trial to test the drug in people with melanoma has shown promising results. The manufacturers of the drug have submitted an application for "breakthrough therapy" designation from the U.S. Food and Drug Administration (FDA) to expedite the FDA-approval process and rapidly make the drug available to many more melanoma patients in the U.S.

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Provectus Biopharmaceuticals  |  Apr 7, 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 test 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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Merck Applies for FDA License for Promising Experimental PD-1 Blocker (MK-3475)

Merck Applies for FDA License for Promising Experimental PD-1 Blocker (MK-3475) | Melanoma Dispatch | Scoop.it

People with melanoma could have a new treatment option soon ─ Merck is applying for a US Food and Drug Administration (FDA) license for a new experimental immunotherapy for this skin cancer. Called MK-3475, the treatment blocks a protein (PD-1) that lets tumor cells evade the immune system. The FDA fast-tracked its review of MK-3475 in 2013 on the strength of clinical trials showing that this drug may extend life in people with melanoma by a year. Merck says the FDA application should be complete in the first half of 2014.

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Merck  |  Jan 13, 2014

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FDA Mulls Change in Cancer Drug Approval Process

FDA Mulls Change in Cancer Drug Approval Process | Melanoma 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 vs 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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Compassionate Use of Unapproved Drugs Raises Difficult Ethical Issues

Compassionate Use of Unapproved Drugs Raises Difficult Ethical Issues | Melanoma 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 decisively judge 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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New York Times | Oct 31, 2013

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New York Times | Oct 31, 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 U.S. Food and Drug Administration (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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FDA Speeds Review of Experimental Immunotherapy for Melanoma

The U.S. Food and Drug Administration (FDA) has fast-tracked the review of lambrolizumab, an immunotherapy drug for melanoma being developed by the pharmaceutical company Merck. Lambrolizumab, also called MK-3475, disrupts a protein called PD-1 that allows tumor cells to evade the immune system. The expedited review was granted on the strength of promising early results from a clinical trial: tumors shrank in half of those treated with lambrolizumab (43 out of 85), and disappeared in another 9%. Encouragingly, tumors also shrank in 11 of the 27 patients (41%) who had previously been treated with ipilimumab, another immunotherapy drug that is currently used to treat melanomas that have spread. Clinical trials with lambrolizumab are also underway for other types of cancer, including non-small cell lung cancer (NSCLC).

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RX Times │ Apr 24, 2013

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