Category Archives: Regulatory applications & approvals

Ariad files FDA application and gets acquired

As of August 30, 2016 Arriad had files its new drug application with the FDA for brigatinib. As of Oct 31, 2016 the FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017. As of January … Continue reading

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Crizotinib approved for ROS1 + lung cancer

On March 11 the FDA approved the selling of Crizotinib for patients with ROS1 mutations in lung cancer. The ORR was 66% and the median DOR was 18.3 months. Safety profile was similar to that in ALK + patients. http://www.businesswire.com/news/home/20160311005839/en/XALKORI%C2%AE-crizotinib-Approved-U.S.-FDA-Treatment-Patients

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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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European Commission expands use of Crizotinib

Around 12-2-2015 the Europe Commission approved Xalkori (Crizotinib) as a first line treatment so it can be given before chemotherapy.

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Two FDA approvals for immunotherapy for NSCLC

In October 2015 FDA approves two immunotherapys nivolumab (Opdivo) and pembrolizumab (Keytruda) for non small cell lung cancer. While not targeted at ALK they are new treatments they could be tried by an ALK+ lung cancer patient, especially if their … 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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Ariad plans to file NDA in 3rd quarter of 2016

Ariad plans to file a new drug application (NDA) for brigatnib in 3rd quarter of 2016. http://investor.ariad.com/mobile.view?c=118422&v=203&d=1&id=2075920

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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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