Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masiviera, intended for the treatment of advanced inoperable pancreatic cancer.
Masiviera is an anticancer medicine that contains the active substance Masitinib. It was to be available as tablets.
Masiviera was expected to be used to treat adults with cancer of the pancreas that is locally advanced or metastatic, non-resectable and is accompanied by at least moderate pain. It was to be used in combination with another cancer medicine, Gemcitabine ( Gemzar ).
Masitinib was designated an orphan medicine ( a medicine to be used in rare diseases ) on 28 October 2009 for the treatment of pancreatic cancer.
The active substance in Masiviera, Masitinib, is a tyrosine-kinase inhibitor. This means that it blocks certain enzymes known as tyrosine kinases. These enzymes can be found in some receptors on the surface of cells, including the receptors that are involved in stimulating cancer cells to divide uncontrollably. By blocking these receptors, Masiviera might help in controlling cell division and thereby slow down the growth of the cancer.
The effects of Masiviera were first tested in experimental models before being studied in humans. The company presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer.
Masiviera was compared with placebo as an addition to treatment with Gemcitabine.
The main measure of effectiveness was how long the patients survived with their disease.
The company also presented various supporting analyses and information from a supportive study.
At the time of the initial evaluation, the CHMP noted that the results of the main study with Masiviera did not show effectiveness in the overall group of patients with advanced or metastatic pancreatic cancer. Although the company presented analyses suggesting that there was a benefit in a subgroup of patients with certain genetic changes associated with more aggressive disease, and in a subgroup of patients with pain, the study was not designed to show benefit in these smaller groups, and the Committee considered that further study would be needed to demonstrate such a benefit.
In addition, Masiviera was associated with significant toxicity.
Furthermore, the CHMP had concerns about the quality of the product, in particular about the impurities to which patients might be exposed and about whether commercial batches of the medicine would have the same quality as those used for the studies.
During the re-examination the CHMP looked again at the data from the company, including a proposal for a conditional authorisation in a restricted group of patients, and also consulted a group of experts in the treatment of pancreatic cancer.
The Committee confirmed its opinion that the effectiveness of Masiviera had not been sufficiently demonstrated in pancreatic cancer.
In addition, some concerns about the quality of the medicine were not yet resolved.
Therefore, the CHMP has concluded that the benefits of Masiviera did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation. ( Xagena )
Source: EMA ( European Medicines Agency ), 2014
XagenaMedicine_2014
