Adalvo has received DCP approval for its Palbociclib film-coated tablets in the EU. It’s a significant step in broadening patient access to an established first-line therapy for breast cancer.
Palbociclib is a CDK4/6 inhibitor therapy indicated for the treatment of hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer.
To bring Palbociclib to patients in your territory and explore our full range of 34 oncology therapies, contact a member of the team.
Available in 75mg, 100mg, and 125mg strengths, Adalvo’s differentiated formulation ensures consistent drug absorption, even in patients using Proton Pump Inhibitors (PPIs) for gastric relief. The tablets are lactose-free and can be taken with or without food, helping to expand access and improve tolerability, adherence and outcomes.
Breast cancer is the most commonly diagnosed cancer in women worldwide, with an estimated 2.3 million new cases each year.
While diagnoses in the US and Europe continue rising by around 1% a year, the rate for early-onset breast cancer in women under 50 is accelerating at rates between 1.4% - 2% annually. This is attributed to a number of factors including delayed childbirth, sedentary lifestyles, and increases in obesity and alcohol intake.
A proven therapy for an increasing patient population
As the first CDK4/6 inhibitor therapy for hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer, Palbociclib has a decade of clinical evidence behind it. It remains the most widely prescribed CDK4/6 inhibitor globally by patient volume.
According to IQVIA, global sales of Palbociclib reached $5.2 billion by Q2 2025.
The DCP approval positions Adalvo for Day-1 launches in key markets upon expiry of relevant patents – enabling our partners to enter a well-established, high value HR+/HER2- oncology segment.
To explore licensing and commercial opportunities for Palbociclib, contact a member of the team today.