Nine drugs recommended for approval by EMA/CHMP, 93 overall in 2015

20 December 2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine new medicines for marketing authorization at its December 2015 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2015 to 93.

The CHMP recommended granting a conditional marketing authorization for Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC), from AstraZeneca (LSE: AZN). The Committee reviewed Tagrisso under EMA’s accelerated assessment program. Conditional approval and accelerated assessment are two of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs.

Another medicine for NSCLC, Portrazza (necitumumab) from Eli Lilly (NYSE: LLY), also received a positive opinion from the Committee, for the treatment of squamous non-small cell lung cancer.

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