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Responses with Crizotinib in MET-Amplified Lung Cancer Show New Targetable Form of Disease

Responses with Crizotinib in MET-Amplified Lung Cancer Show New Targetable Form of Disease | Lung Cancer Dispatch | Scoop.it

"In 2011, the drug crizotinib earned accelerated approval by the US FDA to target the subset of advanced non-small cell lung cancers caused by rearrangements of the anaplastic lymphoma kinase (ALK) gene, and subsequently was granted regular approval in 2013. The drug also has shown dramatic responses in patients whose lung cancers harbored a different molecular abnormality, namely ROS1 gene rearrangements. Previously unreported phase 1 clinical trial results now show that crizotinib may have a third important molecular target. In advanced non-small cell lung cancer patients with intermediate and high amplifications of the MET gene, crizotinib produced either disease stabilization or tumor response. Sixty-seven percent of patients with high MET amplification showed prolonged response to the drug, which lasted from approximately 6 months to nearly 2.5 years."


Editor's note: Crizotinib (aka Xalkori) is a targeted therapy drug that kills cancer cells by targeting certain molecules found in the cells. It was already known that crizotinib works well for some patients with advanced non-small cell lung cancer (NSCLC) whose cancer cells have mutations in the ALK gene and in the ROS1 gene; such mutations, or "molecular biomarkers," are detected by a medical procedure known as "molecular testing," or "genetic testing." Now, scientists say that crizotinib may also be effective for patients with advanced NSCLC whose tumors have abnormally high activity of a protein called MET, which can also be detected via molecular testing.

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ScienceDaily  |  May 31, 2014

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Crizotinib Beyond Progressive Disease Improved Survival in ALK-Positive NSCLC

Crizotinib Beyond Progressive Disease Improved Survival in ALK-Positive NSCLC | Lung Cancer Dispatch | Scoop.it

"Patients with ALK-positive, advanced non–small cell lung cancer who received crizotinib beyond progressive disease demonstrated longer OS than patients who did not continue treatment, according to results of a retrospective study.


"The analysis included 194 patients treated with crizotinib (Xalkori, Pfizer) who experienced progressive disease defined by RECIST criteria. Of them, 120 (62%) demonstrated ongoing clinical benefit and continued treatment with crizotinib for more than 3 weeks."

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Healio  |  Feb 27, 2014

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

Xalkori More Effective than Chemotherapy As Second-Line Treatment in ALK+ Lung Cancer | Lung Cancer Dispatch | Scoop.it

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.

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Medical Xpress  |  Jan 13, 2014

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Crizotinib Can Reduce Kidney Function and Testosterone Levels

Crizotinib Can Reduce Kidney Function and Testosterone Levels | Lung Cancer Dispatch | Scoop.it

A recent study suggests that crizotinib (Xalkori) can reduce kidney function. Lung cancer patients treated with Xalkori saw their kidney function decrease by 23.9% on average. Kidney function recovered when Xalkori was discontinued. However, as patients usually have to take Xalkori for months or years, these findings still warrant caution, especially in patients taking other medications that affect kidney function or with preexisting kidney damage. In an earlier study, investigators had found that Xalkori decreased testosterone levels in 84% of male patients. Because cancer drugs like Xalkori increasingly receive accelerated approval, not all of their side effects are known by the time they are approved. Doctors therefore need to carefully monitor their patients for possible adverse effects.

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Medical Xpress  |  Nov 21, 2013

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UK Health Authority Issues Final Rejection for Cancer Drug Xalkori

UK Health Authority Issues Final Rejection for Cancer Drug Xalkori | Lung Cancer Dispatch | Scoop.it

The UK’s National Institute for Health and Clinical Excellence (NICE) confirmed its decision to reject using National Health Service funding to provide crizotinib (Xalkori) to patients. Xalkori is used for patients with previously treated non-small cell lung cancer (NSCLC) who have mutations in the ALK gene. While NICE acknowledges that Xalkori is effective in these patients, they do not consider its benefit substantial enough to warrant its high cost. Xalkori has been found to extend the time without cancer progression by an average of 5.1 months compared to standard chemotherapy; it is unclear whether it increases overall survival. UK patients can still take Xalkori, but would have to pay the full cost themselves (£37,512 - £51,579 for a complete treatment course).

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PharmaTimes | Sep 25, 2013

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Raja Mudad's curator insight, September 27, 2013 9:31 AM

We are very lucky in this country (so far!!) to be able to use cutting edge, science-based treatments for cancers.  Xalkori (crizotinib) for ALK + patients with lung cancer will not be covered in the UK.

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New Lung Cancer Drug LDK378 Appears Effective

In an ongoing phase I clinical trial, the new lung cancer drug LDK378 showed signs of effectiveness in advanced non-small cell lung cancer (NSCLC) with mutations in the ALK gene. Sixty percent of the patients treated with the highest dose of LDK378, which blocks ALK, benefited from the drug. These effects were seen both in patients who had never been treated with the ALK inhibitor crizotinib (Xalkori) before and patients who had become resistant to Xalkori. LDK378 was declared a Breakthrough Therapy by the FDA in March, a designation intended to expedite the development and approval process of treatments for life-threatening conditions. Novartis, which produces LDK378, is initiating two phase II clinical trials (one examining patients who were previously treated with chemotherapy and Xalkori, the other patients with no history of Xalkori treatment) and planning a forthcoming phase III trial.

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Yahoo! Finance | June 3, 2013

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Xalkori More Successful than Chemotherapy in Lung Cancer Patients with ALK Mutations

Xalkori More Successful than Chemotherapy in Lung Cancer Patients with ALK Mutations | Lung Cancer Dispatch | Scoop.it

Crizotinib (Xalkori) may be more beneficial than chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the ALK gene, a phase III clinical trial found. The patients had previously been treated with chemotherapy, after which their cancer had started to progress again. During the trial, they received either a different chemotherapy agent or Xalkori. Xalkori-treated patients went on average 7.7 months without a worsening of their cancer, compared to 3.0 months in the chemotherapy-treated patients. Patients on Xalkori also experienced better quality of life. This study demonstrates the importance of genetic testing for biomarkers, such as ALK mutation, and prescription of targeted therapies based on these biomarkers.

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ScienceDaily | June 1, 2013

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Lung Cancer Patient with ROS1 Mutation Responds to Xalkori

Lung Cancer Patient with ROS1 Mutation Responds to Xalkori | Lung Cancer Dispatch | Scoop.it

A patient with advanced lung adenocarcinoma, a type of non-small cell lung cancer (NSCLC), had relapsed from, or failed to respond to, numerous chemotherapy agents and targeted therapies and was deteriorating rapidly. Previous molecular testing had found no mutations in commonly tested biomarker genes, but a follow-up test detected a mutation in the ROS1 gene. The patient then started treatment with crizotinib (Xalkori) and experienced a dramatic improvement, including tumor shrinkage. Xalkori treatment has continued for 12 weeks so far, with no sign of cancer progression. This case demonstrates the remarkable effectiveness that Xalkori can have in ROS1-mutant NSCLC, as well as the need for prompt and comprehensive molecular testing for all NSCLC patients.

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Lung Cancer | Apr 4, 2013

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UK Health Authority Provisionally Rejects Funding for Cancer Drug Xalkori

UK Health Authority Provisionally Rejects Funding for Cancer Drug Xalkori | Lung Cancer Dispatch | Scoop.it

The UK’s National Institute for Health and Clinical Excellence (NICE) has provisionally recommended against the use of National Health Service resources to provide crizotinib (Xalkori) to patients. NICE considers the drug to be too expensive for the expected benefit. Xalkori is used to treat patients with previously treated non-small cell lung cancer (NSCLC) who have mutations in the ALK gene. The drug has been approved in the U.S. since August, 2011, and conditionally approved in Europe since October, 2012. Patients in the UK can still get access to Xalkori, but would have to cover the cost (£4,689/$7,100 for a 30-day supply) themselves. NICE’s provisional guidance is up for comment, after which a second draft guidance will be issued. More details at: http://www.pharmatimes.com/Article/13-03-27/NICE_issues_draft_no_for_Pfizer_s_Xalkori_but_opens_consultation.aspx

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PMLiVE  | Mar 27, 2013

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FDA Fast-Tracks Approval Process for Lung Cancer Drug LDK378

The FDA has designated Novartis’s anticancer drug LDK378 as a "breakthrough therapy," thereby placing it on a faster track for FDA approval. Breakthrough therapy is a status reserved for drugs that treat serious conditions and that have been shown by preliminary studies to provide a substantial improvement over currently available treatments. In addition to the drug being eligible for accelerated approval, a company producing a breakthrough therapy receives more guidance from the FDA throughout drug development. LDK378, which inhibits a protein called ALK, is designed to treat non-small cell lung cancer (NSCLC) with a mutation in the ALK gene. It may be effective in patients with ALK-mutant NSCLC who have become resistant to the ALK inhibitor crizotinib (Xalkori).

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Reuters | Mar 15, 2013

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Raja Mudad's curator insight, March 18, 2013 1:09 PM

More drugs approved for Lung cancer. This one will be for patients wit ALK positive mutation who have failed Xalkori.

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ALK Inhibitor Treatment Successful, but New Tests and Resistance Solutions Needed

ALK Inhibitor Treatment Successful,  but New Tests and Resistance Solutions Needed | Lung Cancer Dispatch | Scoop.it

Most patients with advanced non-small cell lung cancer (NSCLC) who have mutations in the ALK gene benefit significantly from treatment with the ALK inhibitor critozinib (Xalkori). The only currently FDA-approved test for these mutations, Abbott’s Vysis Break Apart FISH Probe Kit, may miss some patients with ALK mutations, but additional tests are under investigation. Further research is also exploring strategies to address the development of resistance to Xalkori. Several new ALK inhibitors are currently in development.

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Current Opinion in Oncology | Feb 6, 2013

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Crizotinib Resistance Gene Identified

Crizotinib Resistance Gene Identified | Lung Cancer Dispatch | Scoop.it

Researchers have found that mutation of a gene called MED12 makes non-small cell lung cancer (NSCLC) tumors resistant to the drug crizotinib (Xalkori®). Patients who take crizotinib often develop resistance to the drug as a result of accumulating mutations. This study suggests that drugs called TGF-betaR inhibitors, which are already being tested in clinical trials, may counteract crizotinib resistance in patients with MED12 mutations.

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News-Medical.Net | Nov 22, 2012

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Phase III Study: Crizotinib Prolongs Progression-Free Survival in Previously Untreated ALK-Positive Advanced NSCLC

Phase III Study: Crizotinib Prolongs Progression-Free Survival in Previously Untreated ALK-Positive Advanced NSCLC | Lung Cancer Dispatch | Scoop.it

"In the phase III PROFILE 1014 study, the anaplastic lymphoma kinase (ALK) inhibitor crizotinib (Xalkori) was found to significantly prolong progression-free survival in previously untreated patients with ALK-positive advanced nonsquamous non–small cell lung cancer (NSCLC) compared with standard platinum-based chemotherapy.


"No unexpected safety issues were identified in the current study, and adverse events were consistent with the known safety profile for crizotinib. Efficacy and safety data from this study will be submitted for presentation at a future medical meeting."


Editor's note: Xalkori is a targeted therapy that is meant to treat patients whose tumors have mutations in the ALK gene, as detected by molecular testing.

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The ASCO Post  |  Mar 26, 2014

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Local Radiotherapy May Allow Lung Cancer Patients to Stay on Xalkori Longer

Local Radiotherapy May Allow Lung Cancer Patients to Stay on Xalkori Longer | Lung Cancer Dispatch | Scoop.it

Crizotinib (Xalkori) is effective for patients with non-small cell lung cancer (NSCLC) who have a mutation in the ALK gene, but their cancer usually develops resistance to the drug. However, this resistance may affect only part of the cancer, while the majority of the disease still responds to Xalkori. In such cases, localized radiation may be used to destroy the resistant part of the cancer (a technique dubbed 'weeding the garden') while patients continue to take Xalkori. In a small study, patients treated with this method could take Xalkori almost three times longer than those not eligible for the treatment. Longer times on Xalkori were associated with higher rates of 2-year survival. The average time without further relapse after the first radiation treatment was 5.5 months, and patients could be treated multiple times. Similar approaches may be effective with other targeted therapies.

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Medical Xpress  |  Jan 28, 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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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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More Lung Cancer Patients May Benefit from Xalkori Than Previously Thought

More Lung Cancer Patients May Benefit from Xalkori Than Previously Thought | Lung Cancer Dispatch | Scoop.it

Xalkori (crizotinib) is very effective for most non-small cell lung cancer (NSCLC) patients with mutations in the ALK gene. However, new evidence suggests that current criteria for ALK mutation may be missing patients who could be treated with Xalkori. A recent study of NSCLC patients found that 8.5% had tumors that contained more than 10% cells with ALK mutations, but less than 15%, the current cut-off for 'ALK-positive' lung cancer. These patients may benefit from Xalkori or other ALK inhibitors. Moreover, some patients have atypical ALK mutations that are not detected by the standard test. A patient with such atypical ALK mutations profiled in a recent case study responded well to Xalkori treatment.

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Medical Xpress | Sep 10, 2013

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Case of Resistance to Xalkori Linked to New Mutation in ROS1 Gene

Case of Resistance to Xalkori Linked to New Mutation in ROS1 Gene | Lung Cancer Dispatch | Scoop.it

Crizotinib (Xalkori) is an effective treatment for lung cancer patients with mutations in the ALK or the ROS1 gene. However, patients usually develop resistance to the drug after some time. A patient with advanced non-small cell lung cancer (NSCLC) with a ROS1 mutation improved significantly at first after enrolling in a clinical trial assessing Xalkori. However, after 3 months, her cancer again began to worsen despite continued Xalkori treatment. Genetic testing revealed that she had developed a new, additional mutation in the ROS1 gene that makes cells more resistant to Xalkori. The new mutation was present in all of the tumors that had stopped responding to the drug. A better understanding of the way in which cancer cells develop resistance to targeted therapies is critical for developing new treatments that can overcome drug resistance.

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New England Journal of Medicine | June 1, 2013

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Early Trial of New Lung Cancer Drug CH5424802 Yields Encouraging Results

Many patients with non-small cell lung cancer (NSCLC) who have mutations in the ALK gene benefit from treatment with ALK inhibitors. A phase I/II clinical trial of the new ALK inhibitor CH5424802 determined that the drug was well tolerated and showed signs of effectiveness. Out of 46 patients with ALK-mutant advanced NSCLC, 2 experienced a complete response and 41 a partial response; 40 patients currently remain on the treatment. If future studies confirm the effectiveness of CH5424802, it could offer an additional option to crizotinib (Xalkori), currently the only ALK inhibitor approved for treating ALK-mutant NSCLC. An ongoing clinical trial is investigating whether CH5424802 is beneficial in patients who have become resistant to Xalkori.

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The Lancet | April 30, 2013

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Testing for EGFR and ALK Mutations Recommended for All Lung Adenocarcinoma Patients

Testing for EGFR and ALK Mutations Recommended for All Lung Adenocarcinoma Patients | Lung Cancer Dispatch | Scoop.it

All patients with advanced adenocarcinoma of the lung, a type of non-small cell lung cancer (NSCLC), should be tested for mutations in the EGFR and ALK genes, according to guidelines developed by three prominent professional medical societies. Mutations in these genes predict a much higher likelihood of benefitting from treatment with EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa), or ALK inhibitors like crizotinib (Xalkori), respectively. The tests should be performed for all adenocarcinoma patients as soon as advanced disease is detected, regardless of sex, race, smoking history, or other clinical risk factors.

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MedPage Today | Apr 5, 2013

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ALK Gene Mutations May Present New Treatment Target for Some Lung Cancer Patients with Brain Tumors

Treatment options are limited for patients with non-small cell lung cancer (NSCLC) that has spread to the brain (brain metastases). Standard chemotherapy drugs often cannot penetrate the brain well enough to treat brain tumors, leaving radiation, surgery, or easing of symptoms as the only choices. However, drugs that target specific mutations in tumors may open up new possibilities. Some NSCLC patients who have mutations in the ALK gene are likely to benefit from treatment with ALK inhibitors like crizotinib (Xalkori). A study of NSCLC patients with ALK mutations in their lung tumors showed that ALK mutations were present in their brain tumors, too. This finding suggests that ALK inhibitors may be effective in treating brain metastases in patients with ALK-mutant NSCLC, as long as the drugs can effectively penetrate the brain. Research paper: http://www.lungcancerjournal.info/article/S0169-5002(13)00055-X/abstract

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HealthCanal | Mar 23, 2013

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FDA Approves Automated Scanning System for ALK Gene Mutations

FDA Approves Automated Scanning System for ALK Gene Mutations | Lung Cancer Dispatch | Scoop.it

Three percent to 5% of non-small cell lung cancer (NSCLC) patients have a mutation in the ALK gene and may benefit from treatment with critozinib (Xalkori). In 2011, the FDA approved a test that samples NSCLC tissue and highlights ALK mutations with a glowing tag. Now, the FDA has approved an automated scanning system, GenASIs Scan & Analysis, for examining these tagged tissue samples. The automated system, produced by Applied Spectral Imaging, promises fast, reliable detection of ALK mutations in NSCLC.


Press Release: http://www.spectral-imaging.com/news-and-events/news?elq=666b179d69bb426e96e2bb8761261d25

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SmartBrief | Feb 19, 2013

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CollabRx Updates Online Tool for Finding Targeted Therapies for Lung Cancer

CollabRx Updates Online Tool for Finding Targeted Therapies for Lung Cancer | Lung Cancer Dispatch | Scoop.it

CollabRx has released a new version of its Therapy Finder™ application for lung cancer, an online tool that recommends targeted therapies and clinical trials to physicians based on genetic information about a patient’s tumor. Available at http://therapy.collabrx.com/lung/, the updated application incorporates information about mutations in the ROS1 gene, which can make patients eligible for treatment with a class of drugs called ALK inhibitors, including crizotinib (Xalkori). The new tool also includes updated information about selumetinib, an investigational drug that may benefit patients whose tumors carry a mutation in the KRAS gene.

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GlobeNewswire | Feb 7, 2013

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New Drug Holds Promise for Patients with ALK Mutant NSCLC

New Drug Holds Promise for Patients with ALK Mutant NSCLC | Lung Cancer Dispatch | Scoop.it

Drug-maker Ariad Pharmaceuticals has announced promising initial results from an ongoing clinical trial investigating AP26113 in non-small cell lung cancer (NSCLC) patients. The pill demonstrates anti-tumor activity in patients who test positive for ALK mutation and may also be effective in patients with EGFR mutation. AP26113 has proven beneficial for some ALK+ patients with crizotinib resistance. These results were reported at the annual congress of the European Society for Medical Oncology (ESMO) in Vienna, Austria.

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PMLiVE | Oct 2, 2012

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