Public consultation on cancer medicines

EMA Highlights by Gary Finnegan – The EMA has launched a public consultation on its revised guidelines covering how potential cancer drugs are assessed.  The document provides guidance on all stages of clinical drug development for the treatment of tumours, including drug resistance modifiers or normal tissue protective compounds.

The revised guideline underlines the importance of exploratory studies in order to properly define the most appropriate target population and puts further emphasis on the role of biomarkers. It now also incorporates disease-specific guidance, including new guidance for lung cancer, prostate cancer and revised guidance for blood cancers.

Meanwhile, the Agency has also completed its plan for regulation consultations with health professionals. The EMA will work with a network of European organisations representing doctors, nurses and pharmacists in an effort to include frontline health workers in its decision-making.

The regulator said it wants to avail itself of the best available independent expertise, improve communication with healthcare professionals, and enhance understanding of how medicines are regulated at a European level.

To take part in the network, organisations will need to fulfil a range of criteria, including transparency over funding.

Green light for new drugs

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has approved several new drugs for the European market. These decisions are rubber-stamped by the European Commission but effectively mean a ‘green light’ for marketing the medicines in question.

• Baxter Innovations has received approval for a new vaccine against A/H5N1 influenza. Vepacel, 7.5µg Haemagglutinin (HA) antigen per 0.5ml dose, is intended for the prophylaxis of H5N1 subtype of influenza A in either a pre-pandemic or pandemic situation in adults aged 18 years and older. The active substance of Vepacel is A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated), an influenza vaccine (J07BBOI). Vepacel is a non-adjuvanted vaccine that induces an immune response (circulating antibodies) against the H5N1 antigen. The benefits with Vepacel are its ability to mount an appropriate immune response in individuals from the age of 18 years onwards that are immunologically naïve against the vaccine strain, including immunocompromised and chronically ill subjects. The most common side effects are injection site reactions, headache and fatigue.

• PregLem France SAS have been granted approval for Esmya, a 5mg tablet intended for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. The active substance is ulipristal acetate, a selective progesterone receptor modulator, characterised by tissue-specific partial progesterone antagonist effect. It acts by depriving uterine fibroids of growth stimulation due to progesterone.

• Roche has received the green light for Zelboraf (vemurafenib), a new protein-kinase inhibitor, for the treatment of metastatic or unresectable melanoma. This first-in-class treatment can improve progression-free survival by about four months and overall survival by about three months in patients testing positive for BRAF V600 mutations.