‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Lung Cancer Drug Disappoints in 2 Late-Stage Trials

In a recent phase III clinical trial, the cancer drug dacomitinib was no more effective than a placebo at prolonging survival for patients with advanced non-small cell lung cancer (NSCLC) for whom standard therapy had failed. Like the targeted drugs erlotinib (Tarceva) and gefitinib (Iressa), dacomitinib blocks the protein EGFR, but it also inhibits a number of similar, related proteins. Another trial compared dacomitinib to Tarceva in NSCLC patients who had previously received at least one EGFR inhibitor. Dacomitinib did not increase time without cancer worsening compared to Tarceva. Results from a third phase III trial, which compares dacomitinib to Iressa in NSCLC patients with EGFR mutations, are expected next year.


Interim Results from Lung Cancer Clinical Trial of Tivantinib Remain Ambiguous

An ongoing clinical trial is evaluating the effects of cancer drug tivantinib in non-small cell lung cancer (NSCLC). The trial studies patients with advanced non-squamous NSCLC who do not have any mutations in the EGFR gene. Patients receive erlotinib (Tarceva) either by itself or in combination with tivantinib. Enrollment in the trial was stopped because rates of interstitial lung disease (ILD), which can cause lung scarring, may be higher in patients receiving tivantinib. (No such increased levels of ILD were seen in a different trial using tivantinib.) For the patients already enrolled, overall survival, time without cancer worsening, and percentage of patients experiencing tumor shrinkage all seem increased in tivantinib-treated patients. However, it is not yet clear whether these effects are indeed caused by tivantinib or are due to chance.


New Trial Combines Two Immunotherapies Against Melanoma (Yervoy & Prophage)

Will the FDA-approved immune system booster Yervoy (ipilimumab) work better when combined with an experimental melanoma vaccine? Researchers are about to find out ─ the combination will be tested in a phase II clinical trial of up to 25 people. Ipilimumab doesn’t work on its own in about 70% of people with melanomas. The vaccine, called Prophage, could sharpen immune system attacks because it’s made from people’s own tumors.


Cancer Drug Tafinlar Receives Breakthrough Therapy Designation for Lung Cancer

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.


Xalkori More Effective than Chemotherapy as Second-Line Treatment in ALK+ Lung Cancer

The ALK inhibitor crizotinib (Xalkori) has shown effectiveness in patients with non-small cell lung cancer (NSCLC) who have changes in the ALK gene that make the gene overactive (so-called ‘ALK-positive’ patients). A recent clinical trial compared Xalkori to chemotherapy as a second-line treatment in these patients. Over 300 patients with ALK-positive advanced NSCLC who had undergone one previous round of chemotherapy were treated either with Xalkori or one of the chemotherapy drugs pemetrexed (Alimta) or docetaxel (Taxotere). Tumors shrank in 65% of Xalkori-treated patients, compared to 20% of those receiving chemotherapy. The Xalkori-treated patients also went longer without their cancer worsening, experienced fewer symptoms, and reported higher quality of life.