Janssen’s Erleada expanded in Europe to cover metastatic hormone-sensitive prostate cancer

pharmafile | January 29, 2020 | News story | Research and Development, Sales and Marketing Erleada, Europe, Janssen, pharma 

Janssen’s Erleada (apalutamide) has secured expanded authorisation from the European Commission (EC), approving its label to include the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in adult men when used in combination with androgen deprivation therapy (ADT).

Phase 3 data supplied to support the decision showed that the combo “significantly” improved overall survival (OS) rates compared to placebo in combination with ADT, reducing the risk of death by 33%, while it also displayed a 55% greater benefit in radiographic progression-free survival (rPFS), meeting both of the trials’ primary endpoints.

However, median OS was not reached in either study arm, while 42% of participants receiving the Erleada combo experienced adverse events of Grade 3 or 4, in line with 41% with the placebo combo.  

“Prostate cancer is the most prevalent form of cancer in men throughout Europe, and the expanded approval of apalutamide marks a significant advancement for those living with mHSPC,” said Professor Dr Axel S Merseburger, Chairman of the Department of Urology, Campus Lübeck, University Hospital Schleswig-Holstein in Germany. “In prostate cancer treatment, our primary goal is always to delay progression of disease and prolong survival, to ensure the best possible outcomes for patients. Today’s news is therefore an encouraging development for patients within Europe, for whom the importance of an additional treatment option that can both delay progression and extend survival cannot be underestimated.”

Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, also remarked:  “We are delighted with the EC’s approval of the extended use of apalutamide, which makes an important treatment option potentially available to over 100,000 patients living with mHSPC across Europe. It is vital to fight cancer at this stage of the disease with an efficacious new line of treatment, to delay progression to the late and fatal mCRPC stage and, crucially, prolong survival. Janssen remains committed to transforming treatment outcomes for patients and improving lives throughout the prostate cancer journey.”

Matt Fellows

Related Content


Janssen submits sNDA to FDA for full approval of Balversa

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental …

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …

Latest content