The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a total of eight positive opinions, including three recommendations for new-medicine approvals, endorsement of a single new orphan-medicine product, one biosimilar, one new generic medicine, and a recommendation for a paediatric-use market authorisation.
Implications | The July 2016 meeting of the CHMP issued a total of eight recommendations for new-medicine approvals in the European Union (EU). The committee also published five recommendations for therapeutic indication extensions. Among the most notable positive recommendations are Cabometyx (cabozantinib; Ipsen, France / Exelixis, US) and Kisplyx / Lenvima (lenvatinib; Eisai, Japan) for adult patients with advanced renal-cell carcinoma (RCC), as well as an indication extension for Truvada (tenofovir + emtricitabine; Gilead Sciences, US) as a pre-exposure prophylaxis (PrEP) against HIV-1 infection. |
Outlook | The European Commission will decide on granting final market authorisation within the next two-month period. The probable subsequent market authorisation by the commission will allow full commercialisation of the recommended medicines to take place across all 28 EU member states, as well as Iceland, Liechtenstein, and Norway. |
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) published recommendations for the approval of eight new medicines on 22 July. In addition, the CHMP issued five recommendation for drug indication extensions. The full set of CHMP decisions are available to view here.
EMA accelerated-assessment review for two advanced RCC drugs
Eisai's Kisplyx / Lenvima (lenvatinib) and Ipsen's Cabometyx (cabozantinib) are tyrosine kinase inhibitors indicated for the treatment of advanced renal-cell carcinoma (RCC) in adult patients who have been previously treated with a vascular endothelial growth factor (VEGF)-inhibitor. The recommendation for Kisplyx's approval was based on a Phase II (Study 205) clinical trial of Kisplyx in combination with Afinitor/Votubia (everolimus; Novartis, Switzerland) in which patients demonstrated a significant extension in progression-free survival (PFS) compared with patients administered with Afinitor alone. Median PFS for Kisplyx / Afinitor was 14.6 months, compared with 5.5 months for Afinitor alone. The drug has already been approved in Europe for treating thyroid cancer.
The CHMP recommended Cabometyx's approval as a monotherapy; commercial rights to Cabometyx outside of the United States, Canada, and Japan are held by Ipsen. Overall survival data from a recent Phase III (METEOR) trial of the tablet formulation show that Cabometyx reduces the rate of mortality by one-third compared with Afinitor alone. The drug also demonstrated an increase in median overall survival of 21.4 months versus 16.5 months for Afinitor – equivalent to a 34% reduction in mortality risk (see France - United States: 6 June 2016: Exelixis and Ipsen announce Phase III results of Cabometyx targeting advanced renal cell carcinoma).
Other highlights of the CHMP recommendations included positive opinions for the indication extension of Gilead Sciences' Truvada (emtricitabine 200 mg + tenofovir 300 mg) as a pre-exposure prophylaxis (PrEP) against HIV-1 infection. At the start of 2016, France became the first European Union (EU) country to authorise (through a temporary-use order) the use of Truvada as a preventive treatment (see France: 24 November 2015: French health ministry to reimburse Truvada as preventive treatment against HIV infections). Political pressure is building in a number of EU countries, including the Netherlands, for the early reimbursement of Truvada as a PrEP. Studies have shown that daily use of the drug in high-risk groups (including homosexual and bisexual men and sex workers) reduces the risk of HIV transmission by 86% compared with a placebo-controlled group. The drug is reportedly priced at EUR500 (USD532) for 30 tablets. Gilead is likely to experience a substantial boost to its anti-retroviral business over the coming quarters; the US firm posted a 16.5% year-on-year increase in sales of Truvada in its latest results statement to USD898 million (see United States: 5 May 2016: Gilead's HCV drug sales fall short of expectations in Q1).
Cabometyx (cabozantinib; 20 / 40 / 60 mg film coated tablets) | Ipsen (France) / Exelixis (US) | Treatment of advanced renal-cell carcinoma (RCC) in adult patients following prior vascular endothelial growth-factor (VEGF)-targeted therapy |
Kisplyx (lenvatinib; 4 mg and 10 mg hard capsules) | Eisai (Japan) | Indicated for the treatment of unresectable advanced or metastatic RCC in adult patients in combination with everolimus, following one prior vascular endothelial growth-factor (VEGF)-targeted therapy |
Onivyde (Irinotecan) | Baxter (UK) | Treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine therapy |
Sialanar (glycopyrronium bromide) | Proveca (UK) | Under a re-examination procedure, Sialanar was indicated for symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged three years and older with chronic neurological disorders |
Truberzi (eluxadoline) | Aptalis Pharma (subsidiary of Allergan, US) | Medical prescription drug indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
Source: European Medicines Agency | ||
Outlook and implications
The CHMP recommendations published at the July meeting are highly likely to be approved by the European Commission within two months, which will still fall within the third quarter of 2016. European Commission approval would be effective throughout all 28 EU countries (as well as Norway, Iceland, and Liechtenstein). The most significant points of the latest CHMP meetings are the positive opinions for an indication extension for Truvada, and the recommendations for the RCC drugs Kisplyx / Lenvima and Cabometyx; Ipsen and Exelixis had previously indicated as recently as April 2016 that Cabometyx would be priced competitively with other tyrosine kinase inhibitors used to treat advanced RCC. Information published on Exelixis' website in June 2016 (available here) suggests that the wholesale acquisition cost for Cabometyx in the United States for a one-month supply (at all three dosage levels – i.e 20 mg, 40 mg, and 60 mg) is USD13,750.