close

Products

Date: 2014-01-27

Type of information: Granting of a patent

Product name: Masiviera®

Compound: masitinib

Therapeutic area:

Action mechanism:

Masitinib, is a tyrosine-kinase inhibitor. Tyrosine kinases 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.

Company: AB Science (France)

Disease:

advanced inoperable pancreatic cancer

Latest news:

* On May 22, 2014, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation for Masiviera® intended for the treatment of advanced inoperable pancreatic cancer. On 23 January 2014,the (CHMP) had already adopted a negative opinion, recommending the refusal of the marketing authorisation. AB Science requested a re-examination of the opinion. 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 concluded that the benefits of Masiviera® did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
* On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending the refusal of the marketing authorisation for Masiviera®, intended for the treatment of advanced inoperable pancreatic cancer. 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 or has certain genetic changes that are associated with more aggressive disease. It was to be used in combination with gemcitabine. The effects of Masiviera® were first tested in experimental models before being studied in humans. AB Science presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer. Masiviera® was compared with placebo (a dummy treatment) 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.
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.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Masiviera® did not outweigh its risks and recommended that the medicine be refused marketing authorisation.
Masitinib (Masican®) is also being assessed for the treatment of gastrointestinal stromal tumour (GIST). Last December,AB Science has requested a re-examination of the CHMP’s November 2013 negative opinion. Upon receipt of the grounds for the request, the CHMP will re-examine its opinion and issue a final recommendation.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE: 2009-10-28

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes