Cancer drug: EMA recommends new drug against pancreatic cancer

Amsterdam. The European Medicines Agency (EMA) recommends the approval of a drug against pancreatic cancer in the EU. The drug daraxonrasib is recommended for adults with metastatic pancreatic cancer who have previously received at least one other treatment, the authority announced.

Patients whose disease has worsened after previous treatment have a poor prognosis and only limited treatment options, the statement continues. Given the severity of the disease and the limited effectiveness and disadvantages of standard chemotherapy, there is a need for better treatment options.

The manufacturer Revolution Medicines sells the drug under the name “Rasonque,” ​​and it has already been approved in the USA for patients with metastatic pancreatic cancer under certain conditions.

Pancreatic cancer is very dangerous

According to the Cancer Information Service and the Robert Koch Institute (RKI), around 20,000 people in Germany develop pancreatic cancer every year. The type of cancer is one of the deadliest: according to the RKI Center for Cancer Registry Data, only around one in ten people are still alive five years after diagnosis. In the early stages, those affected often feel no or only unspecific symptoms, so that the tumor is often only recognized late.

In a phase III study with 500 patients, patients whose condition had worsened after other therapy survived about twice as long with the drug daraxonrasib as patients who were treated with chemotherapy - according to the EMA, a median of 12.4 months instead of 6.7 months.

Growth of tumors should be inhibited

The drug's mode of action is aimed at inhibiting the growth of tumors. It is aimed at cancer patients with certain mutations that are very common in pancreatic cancer. A cure is not expected.

Examination in an accelerated procedure

The EMA examined the drug in an accelerated procedure, which is used when a drug has the potential to meet an urgent medical need. Available data is assessed before the complete application for approval is submitted. According to the EMA recommendation, the EU Commission still has to grant the drug market approval.

The Federal Institute for Drugs and Medical Devices was involved in the testing process. The president of the institute, Karl Broich, explained: "It is crucial for patients with serious illnesses that medical innovations become available as quickly as possible. 'Rasonque' shows that in the European approval system we are able to significantly accelerate procedures when there is high medical need, without compromising on scientific evaluation."