Category Archives: Regulatory applications & approvals

Imunotherapy update for NSCLC (not squamous cell)

On April 17 it was announced that a large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, non-small cell lung cancer (NSCLC). When a similar … Continue reading

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Imunotherapy approved for Squamous NSCLC

On March 4 the FDA approved Opdivo (Nivolumab) by Bristol-Myers for the treatment of Squamous NSCLC who have previously been treated by at least one chemotherapy. Patients do not have to have PD-L1 expression in order to get the drug. … Continue reading

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Another imunotherapy update

On January 11th, Bristol-Myers announced the early termination of its trial of imunotherapy Opdivo (Nivolumab) for lung cancer due to positive results (a survival benefit that was so clear it was unethical to continue the trial for the control group). … Continue reading

Posted in Lung cancer, Potential Treatments, Regulatory applications & approvals, Research, Uncategorized | Leave a comment

Xcovery updates results on x-396

At the time of data cutoff, 41 patients were enrolled with tumor types including NSCLC, head and neck, small cell lung, colorectal and breast cancers. The NSCLC (n=33) patient group included ALK-positive patients (n=23) who were either crizotinib-naïve (n=5) or … Continue reading

Posted in Brain metastases, Lung cancer, Regulatory applications & approvals, Research, X-396 - ensartinib from Xcovrery | Leave a comment

Article by Dr. Shaw on current status of ALK Inhibitor drugs

Dr. Shaw has written a comprehensive article on all 10 ALK Inhibitors being developed as of July 7, 2014. It provides comparisons of testing status, concentration levels, side effects and much more. It also includes a 2 page list of … Continue reading

Posted in alectinib - Alecensa from Chugai - Roche - GenenTech, AP26113 - brigatinib from Ariad, Brain metastases, CEP-37440, ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, Lung cancer, NMS-E628, Potential Treatments, Regulatory applications & approvals, Research, Resistance to treatment, RXDX-101 - entrectinib - by Ignyta, Side Effects, TSR-011 from Tesaro, X-396 - ensartinib from Xcovrery | Leave a comment

List of 8 ALK Inhibitors in trials

List of 8 ALK inhibitor drugs currently in clinical trials: FDA approved (but several trials ongoing) Pfizer – Crizotinib (2011 initial, 2013 final) Novartis – Ceritinib (2014 initial) FDA Breakthrough Status Chugai – Alectinib (approved in Japan in 2014) Ariad … Continue reading

Posted in alectinib - Alecensa from Chugai - Roche - GenenTech, AP26113 - brigatinib from Ariad, ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, Lung cancer, Regulatory applications & approvals, Research, RXDX-101 - entrectinib - by Ignyta, TSR-011 from Tesaro, X-396 - ensartinib from Xcovrery | Leave a comment

List of 9 ALK Inhibitors

List of 9 ALK inhibitor drugs currently in clinical trials: FDA approved (but several trials ongoing) Novartis – Ceritinib Pfizer – Crizotinib FDA Breakthrough Status Chugai – Alectinib (filed NDA in Japan) Ongoing trials Ariad AP26113 Nerviano NMS-E628. (Licensed by … Continue reading

Posted in alectinib - Alecensa from Chugai - Roche - GenenTech, AP26113 - brigatinib from Ariad, CEP-37440, ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, Lung cancer, NMS-E628, Potential Treatments, Regulatory applications & approvals, Research, RXDX-101 - entrectinib - by Ignyta, TSR-011 from Tesaro, X-396 - ensartinib from Xcovrery | Leave a comment

FDA approves LDK378 (Ceritinib).

Novartis gains FDA approval for Zykadia(TM). Breakthrough therapy drug approved four months ahead of review completion goal date. http://www.novartis.com/newsroom/media-releases/en/2014/1776962.shtml http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395299.htm For an interesting commentary see: http://cancergrace.org/lung/2014/04/30/new-approval-for-zykadia-ldk378ceritinib-in-alk-positive-nsclc-why-it-matters-even-if-youre-not-alk-positive/#more-14473

Posted in Brain metastases, ceritinib - Zykadia from Novartis, Lung cancer, Potential Treatments, Regulatory applications & approvals, Resistance to treatment, Side Effects | Leave a comment

ESMO – Next Generation ALK Inhibitors

Here is a summary of a presentation on next generation ALK inhibitors. ESMO Presentation

Posted in alectinib - Alecensa from Chugai - Roche - GenenTech, AP26113 - brigatinib from Ariad, ceritinib - Zykadia from Novartis, Lung cancer, Potential Treatments, Regulatory applications & approvals, Research, Resistance to treatment, Side Effects | Leave a comment

LDK378 (Ceritinib) Study Published in NEJM

A couple of people have kindly pointed out that I have been reading these medical studies for too long and I am starting to sound like them. For short summary see bottom of post. So here is an attempt to … Continue reading

Posted in Brain metastases, ceritinib - Zykadia from Novartis, Lung cancer, Potential Treatments, Regulatory applications & approvals, Research, Resistance to treatment, Side Effects | Leave a comment