Layer 1

EMA pushes for cancer drugs to get early authorisation

Clinical The European Medicines Association has recommended that three new cancer drugs receive marketing authorisation via the UK’s early access to medicines scheme

The European Medicines Association (EMA) has recommended that three new cancer drugs receive marketing authorisation via the UK's early access to medicines scheme.


The EMA's Committee for Medicinal Products for Human Use (CHMP) has put forward Vynfinit (vintafolide) to treat platinum-resistant ovarian cancer, as well as two companion diagnostic drugs – Folcepri (etarfolatide) and Neocepri (folic acid) – it announced on Friday (March 21).


Researchers had found Vynfinit, which works by binding to the folate receptors on the surface of cancer cells to deliver the medicine to the target, improved survival in patients during a phase-2 clinical trial.


Although phase 3 was still ongoing and comprehensive data was not yet available, the early access to medicines scheme, launched in the UK last week (March 14), allowed the EMA to recommend the drug because it addressed an "unmet medical need," it said.


The EMA is pushing for Vynfinit to be authorised because it addresses an "unmet medical need" in ovarian cancer

More on the EMA

EMA recommends lower dose of nausea relief drug

Fresh warning on osteoporosis drug

EMA reviews effectiveness of morning-after pill for overweight women


The triple recommendation followed current trends in developing medicines where specific patients were targeted, based on a better understanding of underlying molecular mechanisms, the EMA said. As a result, treatment could be avoided in patients who were unlikely to respond to it, sparing them potential side effects, it added.


The EMA also recommended marketing authorisation for the Crohn's disease treatment Entivyo (vedolizumab), which was aimed specifically at adults unresponsive to conventional therapy.


The recommendations will be referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will decide whether they should be enforced across Europe, including the UK.

0 Comments
Login or register to post comments

Job of the week

Pharmacist / Manager
Doncaster, South Yorkshire
To be negotiated + benefits