Category Archives: alectinib – Alecensa from Chugai – Roche – GenenTech

Alectinib approved by FDA

The FDA conditionally approved alectinib (brand name Alecensa) on December 11, 2015 as a second line treatment. This approval came less than 3 months after the FDA application was filed. The approval was based on results from two single-arm clinical trials. … Continue reading

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Editorial on Brain mets and ALK lung cancer

The Journal of Clinical Oncology has an editorial about the current research on treating brain mets for ALK+ patients that discusses ALK inhibitors and different kinds of radiation treatments. Treatments discussed include: 1) Crizotinib, 2) Ceritinib 3) Alectinib 4) brigatinib, … Continue reading

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Phase II results for Alectinib global study

Published November 23, 2015, Phase II trial results. Patients enrolled from June 2013 to April 2014. 122 evaluable patients who were all resistant to Crizotinib; overall objective response rate (ORR) of 50%. Disease Control Rate (DCR) was 79%. Median duration … Continue reading

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Survey of ALK inhibitors effects on brain mets

This survey summarizes the results of other research to describe the current level of knowledge about how effective different ALK inhibitors are at treating brain mets. Inhibitors that are discussed include crizotinib, ceritinib, alectinib, AP26113 (brigatinib) and PF-06463922 (lorlatinib). http://www.thecco.net/article/view/6520/7543

Posted in 3922 - lorlatinib by Pfizer, alectinib - Alecensa from Chugai - Roche - GenenTech, AP26113 - brigatinib from Ariad, Brain metastases, ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, Lung cancer, Potential Treatments, Research | Leave a comment

Comparison of different diagnostic tests

A comparison of the Fluorescence in-situ hybridization (FISH) test and ALK immunohistochemistry (IHC) for determining ALK + status. Basically the tests have results that are 99% consistent. The authors argue that either test should be sufficient on its own to determine … Continue reading

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NDA filed for alectinib

On September 9 a new drug application was filed by Genentech for Alectinib. The FDA granted priority review status. It already has breakthrough therapy status.

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Roche/Genentech to file NDA in 2015

Back in May 14, 2015, Roche announced its plans to file a new drug application for Alectinib in 2015. http://www.roche.com/media/store/releases/med-cor-2015-05-14.htm According to several postings on Inspire.com by patients, Alectinib approval by the FDA is expected by the end of October. … Continue reading

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Comparison of 3 ALK inhibitors’ phase 2 trials

All of these results are based on 5 phase 2 trials. However the conditions of each trial may differ in important ways. For example, it is my understanding that the trial for brigatinib was limited to healthier patients while the … Continue reading

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3 Alectinib abstracts

Here is a summary of abstracts 8061, 8019, and 8008. Please see glossary for acronym definitions. Abstract 8061 is an update on a phase 1/2 trial of 46 Crizotinib naïve patients in Japan. As of 10-31-2014, median PFS has not … Continue reading

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ASCO links

Here are 18 ALK+ related abstract links related to the drugs listed below. On the ASCO website 77 abstracts refered to both “ALK” and “Inhibitor”.  When I get a chance I will write up a summary on some of the … Continue reading

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