EU Panel Likes ALL Drugs and Generics for Lung Cancers

Nick Mulcahy

November 20, 2015

At its November meeting, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) issued recommendations on drugs for acute lymphoblastic leukemia (ALL) and lung malignancies.

The CHMP recommended granting marketing authorization for pegaspargase (Oncaspar, Baxalta Innovations GmbH) and asparaginase (Spectrila, Medac Gesellschaft für klinische Spezialpräparate mbH), both for the treatment of ALL.

Pegaspargase is already available in some countries in the European Union; it was authorized in 1994 in Germany and in 2008 in Poland for the treatment of patients with ALL who were hypersensitive to native forms of asparaginase.

Asparaginase is administered as part of combination chemotherapy, the goal of which is to increase the proportion of patients who achieve complete remission at the end of the treatment period.

Two generic cancer medicines received positive opinions from the committee. Accord's pemetrexed got a thumbs up for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small-cell lung cancer.

Likewise, Actavis's pemetrexed received a positive opinion for the same indication. This is a hybrid application, which relies in part on results from studies carried out with a reference product and in part on new data.


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