Adalvo's Apalutamide development continues to progress, with the regulatory dossier targeted for completion in Q4 2026. This supports a well-prepared Day-1 submission in Europe following data exclusivity, and early market access across multiple regions.
Developed as a generic of Erleada®, Apalutamide is one of the most commercially successful prostate cancer therapies of its generation. It is indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT).
To discuss licensing opportunities for Apalutamide, contact the team today.
Prostate cancer is the most commonly diagnosed cancer in men. An April 2024 study by The Lancet found that global case numbers are set to double by 2040, reaching approximately 2.9 million annually — meaning the demand for effective, accessible treatments will grow in step.
Apalutamide's strong clinical profile — including a 35% reduction in mortality risk and 52% delay in disease progression versus ADT alone — underpins both its first-line guideline status and its sustained commercial performance.
Adalvo is developing Apalutamide in both 60 mg and 240 mg strengths, supporting
prescriber flexibility and compatibility with country-specific product strategies.
According to IQVIA, global sales of Apalutamide reached approximately $5.2 billion in 2025, representing a three-year CAGR of 31%, reflecting both its clinical importance and strong commercial demand.
To explore Adalvo's full oncology portfolio of 34 therapies, get in touch.