Date: 2017-06-01
Type of information: Withdrawal of a market application in the EU
Product name: Zafiride®
Compound: NGR-hTNF
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- fusion protein. NGR-hTNF is a vascular targeting agent and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumour vasculature. It consists of a tumour homing peptide (NGR) that selectively binds tumour blood vessels, fused to the human cytokine.
NGR-hTNF is being investigated in a large clinical program, including a Phase III trial in malignant pleural mesothelioma and Phase II trials in six indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas.
Company: MolMed (Italy)
Disease: mesothelioma
Latest news:
- • On June 1, 2017, MolMed officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride® for the treatment of advanced malignant pleural mesothelioma.
- The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. The company had not yet responded to the questions at the time of the withdrawal.
- Based on the review of the data, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Zafiride could not be approved for the second-line treatment of advanced malignant pleural mesothelioma in patients whose disease had worsened within 6 months of treatment with pemetrexed. The CHMP noted there was inadequate information in several areas of the application, including on the manufacture of the medicine, its testing in humans and animals and its safety. With regard to the
medicine’s effectiveness, the main study did not show convincingly that Zafiride® was better than placebo at prolonging lives in the intended patients. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zafiride® did not outweigh its risks.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it would
be unable to provide requested data on the medicine’s manufacture within the required time frame.
- • On December 23, 2016, MolMed announced that the European Medicines Agency (EMA) has validated the submission of the Conditional Marketing Authorisation (CMA) application for NGR-hTNF as treatment of adult patients with malignant pleural mesothelioma progressing within six months after the first-line pemetrexed-based therapy. Review of the submitted dossier therefore starts on the same day.
Patents:
- • On September 6, 2013, MolMed has announced receipt of the official notification from the European Patent Office of the decision to grant a patent covering the therapeutic use of its investigational anticancer drug NGR-hTNF at low doses (EP1499730). The grant will take effect on the 2nd of October 2013, when it will be published in the European Patent Bulletin. This new European patent on NGR-hTNF becomes part of a large proprietary patent family which comprises 7 granted patents and 3 patent applications filed in the most important pharmaceutical markets, including the United States, Japan, Canada, Australia and China. The patent will afford protection until 2023 and will give right to market exclusivity in 27 European countries, including European Union member states, Eastern Europe countries, Switzerland and Turkey.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE: 2017-06-01
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2008-08-22
Orphan status UE: 2008-06-03
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
