July 29 2013 | By Márcio Barra
EMA’s CHMP 22-25 July 2013 saw 8 new drugs obtaining a positive opinion for a marketing authorization (MA). Here is the rundown of approvals:
Approved marketing authorizations for new drugs:
Giotrif (afatinib), Boehringer Ingelheim International GmbH – Giotrif is an antineoplastic drug for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. The drug is the first irreversible ErbB family blocker, a group of receptor tyrosine kinases overexpress in many cancers. This is the third drug to target EGFR mutations in NSCLC, joining erlotinib (Tarceva) and gefitinib (Iressa).
The CHMP’s positive opinion for Giotrif is based on data from the pivotal trial LUX-Lung,comparing afatinib to chemotherapy with pemetrexed/cisplatin. Results from the study showed that patients taking afatinib lived for almost one year without their tumour growing again versus just over half a year for those treated with pemetrexed/cisplatin.
Afatinib was
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DRUG REGULATORY AFFAIRS INTERNATIONAL 