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[HEALTH] · United States, Germany, Spain, Italy, Netherlands · 18 sources

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Part of situation: FDA approves Rasonque; EMA recommends for pancreatic cancer (44 clusters)

EMA recommends approval of Daraxonrasib for metastatic pancreatic cancer

daraxonrasib Rasonque pancreatic cancer European Medicines Agency Revolution Medicines

The European Medicines Agency (EMA) has recommended the approval of daraxonrasib, marketed under the trade name ‘Rasonque’, for the treatment of adults with metastatic pancreatic adenocarcinoma who have undergone at least one prior treatment. Developed by the American pharmaceutical company Revolution Medicines, the oral medication targets specific genetic mutations by inhibiting RAS proteins to slow tumor growth.

A Phase III clinical study involving 500 patients demonstrated that daraxonrasib significantly extended survival compared to standard chemotherapy. Patients receiving the drug had a median survival of 12.4 months, whereas the chemotherapy control group had a median survival of 6.7 months. Additionally, the drug provided a median of 7.2 months without disease progression, compared to 3.6 months for those on chemotherapy.

The EMA reviewed the drug through an accelerated assessment procedure due to its potential to meet urgent medical needs. Following this recommendation from the Committee for Medicinal Products for Human Use (CHMP), the final decision regarding marketing authorization rests with the European Commission. Once approved, individual EU member states will determine pricing and reimbursement within their respective national healthcare systems.

Entities

European Commission · European Medicines Agency · German Cancer Society · Revolution Medicines · Robert Koch Institute · Thomas Seufferlein · daraxonrasib · daraxonrasib

Claims

What the coverage asserts, and how many sources carry each claim.

Sources

BE-ja rekomandon miratimin e ilaçit të ri kundër kancerit të avancuar të pankreasit [fjala.al]
Könnte Überlebenszeit fast verdoppeln: Neues Medikament gegen Krebsart vor EU-Zulassung [www.t-online.de]
Európska agentúra pre lieky odporúča schváliť nový liek na rakovinu pankreasu [europske.noviny.sk]
Tumore al pancreas, agenzia europea dà via libera a nuovo farmaco [www.codirp.it]
Daraxonrasib e tumore al pancreas: il parere EMA [www.tantasalute.it]
Rassegna stampa del 17 ottobre 2026 [www.torrinomedica.it]
Комитетът по лекарствата за употреба в хуманната медицина (CHMP) на [novini247.com]
MEDICAMENTOS | Así es 'Rasonque', la pastilla autorizada por Europa que duplica la supervivencia en cáncer de páncreas [www.informacion.es]
Mogelijk eerste medicijn voor uitgezaaide alvleesklierkanker [www.rd.nl]
Neue Therapie gegen tödliche Krebsform – Was bringt sie? [www.fehmarn24.de]
EMA empfiehlt Zulassung von Daraxonrasib (Rasonque) bei metastasiertem Pankreaskarzinom [www.it-boltwise.de]
Sopravvivenza mediana di 12,4 mesi: la nuova pillola per il cancro al pancreas Rasonque ottiene il via libera dell'EMA | Le notizie dall’Italia e dal mondo - upday News [www.upday.com]
Tumore al pancreas, agenzia europea dà via libera a nuovo farmaco [www.trapanisi.it]
Tumore al pancreas, agenzia europea dà via libera a nuovo farmaco - Il Quotidiano del Sud [www.quotidianodelsud.it]
Neue Therapie gegen tödliche Krebsform – Was bringt sie? [www.op-online.de]
Krebsmedikament: Neue Therapie gegen tödliche Krebsform - Was bringt sie? [www.volksfreund.de]
Neue Therapie gegen tödliche Krebsform – Was bringt sie? [www.nordbayern.de]
Europa apuesta por el fármaco que duplica la supervivencia en pacientes con cáncer de páncreas [www.20minutos.es]