Adalvo continues to progress its Apalutamide development program, with the regulatory dossier expected to be completed by the end of 2025, paving the way for early market access in several regions, including LATAM, APAC and CIS. Additionally, a DCP slot has been secured for Q1 2026.
Adalvo is developing Apalutamide in 60 mg and 240 mg strengths, ensuring both prescriber flexibility and compatibility with country-specific product strategies.
Developed as a generic version of Erleada®, Apalutamide is a novel androgen receptor inhibitor indicated for the treatment of both non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT).
Erleada® is currently the only once-daily, single-tablet formulation in its class. Clinical studies have demonstrated that Apalutamide + ADT can reduce the risk of death by 35% and delay disease progression by 52% compared to ADT alone.
According to IQVIA, global sales of Apalutamide reached approximately $3.9 billion in 2024, with a 3Y CAGR of 36%, highlighting both its clinical relevance and commercial strength.
Adalvo’s program is built on a robust technical foundation and a clearly defined regulatory pathway, aimed at delivering a partner-ready oncology product with strong market potential and first-wave launch opportunity.
To explore licensing or partnership opportunities within Adalvo’s oncology portfolio, contact the team today.