The US FDA approved Verzenio based on results from Phase 3 monarchE trial in adults with HR+ HER2-, node-positive, resected EBC

1200px-Eli_Lilly_Corporate_Center,_Indianapolis,_Indiana,_USA

Eli Lilly and Company's corporate centre in Indiana. (Credit: Momoneymoproblemz/Wikipedia.)

Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for its Verzenio (abemaciclib) to treat a type of early breast cancer (EBC).

The drug, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), was indicated for the adjuvant treatment of HR+, HER2-, node-positive, EBC in adults.

It was indicated for HR+, HER2- EBC patients who are at risk of recurrence, with a Ki-67 score (a marker of cellular proliferation) ≥20% as determined by an FDA-approved test.

Verzenio is a non-chemotherapy oral medication that works to block the activity of cyclin-dependent kinases CDK4/6 to prevent the growth of cancer cells.

Lilly claims that Verzenio is its first solid oral dosage form to be produced using continuous manufacturing, an advanced, rapid, effective production process.

Also, it the first and only CDK4/6 inhibitor approved for the current patient population, after nearly two decades, said the company.

Loxo Oncology at Lilly CEO and Lilly Oncology president Jacob Van Naarden said: “Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile.

“We are pleased with this initial approval in the adjuvant setting and as these data continue to mature, we look forward to further opportunities to work with health authorities to expand the use of Verzenio in this setting.”

The US FDA approved Verzenio based on results from Phase 3 monarchE trial in adults with HR+ HER2-, node-positive, resected EBC, with risk of disease recurrence.

In the Phase 3 trial, patients were given ether a combination of Verzenio 150mg plus standard endocrine therapy, or standard endocrine therapy alone, for two years.

Invasive disease-free survival (IDFS) is the primary endpoint of the study, which was met at a pre-specified interim analysis in the intent-to-treat (ITT) population.

IDFS is the time required by the breast cancer to comes back, or develop a new cancer, or death, according to the expert guidelines.

Patients treated with Verzenio plus ET showed a statistically significant improvement in IDFS compared to those treated with ET alone, said Lilly.

The monarchE study investigator Sara M Tolaney said: “The design and results of the monarchE study are practice-changing and represent the first advancement in adjuvant treatment of HR+ HER2- breast cancer in a very long time.

“This FDA approval for Verzenio in combination with endocrine therapy in the early breast cancer setting has the potential to become a new standard of care for this population.

“We are encouraged by the marked reduction in the risk of recurrence even beyond the two-year treatment period in these patients, and I’m grateful to be able to offer this as a treatment option to my patients.”