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Lilly's (LLY) Verzenio Gets FDA Nod for Expanded Breast Cancer
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Eli Lilly and Company (LLY - Free Report) recently announced that the FDA has approved the expanded use of Verzenio (abemaciclib), in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, early breast cancer (EBC) at a high risk of recurrence. Per the company press release, patients at high risk, eligible for treatment with Verzenio, can be identified on the sole basis of nodal status, tumor size and tumor grade.
In October 2021, the FDA approved Verzenio in combination with either tamoxifen or an aromatase inhibitor after surgery to treat early-stage HR+, HER2-negative, node-positive breast cancer with high recurrence risk and a Ki-67 score of 20% or greater.
The expanded adjuvant indication eliminated the Ki-67 score requirement for patient selection approved in 2021 as mentioned above.
Lilly’s Verzenio, a non-chemotherapy oral tablet, is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6).
The recent label expansion of Verzenio was based on four-year data from the phase III monarchE study. Per the data, 85.5% of patients were recurrence-free on treatment with Verzenio plus ET, compared with 78.6% with ET alone, representing an absolute difference in invasive disease-free survival of 6.9%, after four years of treatment.
The absolute differences at the two years and three years mark were 3.1% and 5.0%, respectively. It was also observed that Verzenieo, in combination with ET, reduced the chances of recurrence by 35%. The safety profile of the drug was also constant with previously established results.
Per management, based on the results of the four-year study, adjuvant Verzenio should be the standard of care for high-risk patients in EBC. It also claims to be able to reduce breast cancer recurrence in far more patients with this indication expansion than was possible with the initial approval as identification of the same has become simpler.
Along with the label expansion in EBC, the FDA also increased the scope of use of Verzenio in metastatic breast cancer (MBC), upon use in combination with an aromatase inhibitor, as initial endocrine-based therapy for the treatment of adult patients with HR+, HER2- advanced or MBC. The updated MBC indication now includes all patients, including pre/perimenopausal women, under expanded indication, subjective to use in combination with ovarian suppression.
According to popular statistics, more than 300,000 patients are suspected to be diagnosed with breast cancer in the United States in 2023, 90% of which are expected to be detected at an early stage. Approximately 70% of all breast cancer cases are the HR+, HER2- subtype, most of them advancing to incurable metastatic disease.
There is, however, significant competition in the market from other pharma bigwigs like Pfizer, Inc. (PFE - Free Report) and Novartis AG (NVS - Free Report) , with their breast cancer drugs, following the same mechanism of action. Pfizer’s Ibrance (palbociclib), in combination with Letrozole, was first approved by the FDA in February 2015, for the treatment of postmenopausal women with estrogen receptor-positive (ER+), HER2- MBC.
Verzenio already competes with Ibrance for the treatment of MBC, the latter having been approved for several expanded indications of MBC. In October 2020, Pfizer announced the failure to meet the primary endpoint in a label-expanding PENELOPE-B study of Ibrance for the treatment of EBC. Novartis’ Kisqali (ribociclib, LEE011), in combination with any aromatase inhibitor, was first approved by the FDA in March 2017, for the treatment of postmenopausal women with HR+, HER2- MBC. Novartis has announced several label expansions of Kisqali since its launch and accounts for an important driver of Novartis’ product revenues.
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Lilly's (LLY) Verzenio Gets FDA Nod for Expanded Breast Cancer
Eli Lilly and Company (LLY - Free Report) recently announced that the FDA has approved the expanded use of Verzenio (abemaciclib), in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, early breast cancer (EBC) at a high risk of recurrence. Per the company press release, patients at high risk, eligible for treatment with Verzenio, can be identified on the sole basis of nodal status, tumor size and tumor grade.
In October 2021, the FDA approved Verzenio in combination with either tamoxifen or an aromatase inhibitor after surgery to treat early-stage HR+, HER2-negative, node-positive breast cancer with high recurrence risk and a Ki-67 score of 20% or greater.
The expanded adjuvant indication eliminated the Ki-67 score requirement for patient selection approved in 2021 as mentioned above.
Lilly’s Verzenio, a non-chemotherapy oral tablet, is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6).
The recent label expansion of Verzenio was based on four-year data from the phase III monarchE study. Per the data, 85.5% of patients were recurrence-free on treatment with Verzenio plus ET, compared with 78.6% with ET alone, representing an absolute difference in invasive disease-free survival of 6.9%, after four years of treatment.
The absolute differences at the two years and three years mark were 3.1% and 5.0%, respectively. It was also observed that Verzenieo, in combination with ET, reduced the chances of recurrence by 35%. The safety profile of the drug was also constant with previously established results.
Per management, based on the results of the four-year study, adjuvant Verzenio should be the standard of care for high-risk patients in EBC. It also claims to be able to reduce breast cancer recurrence in far more patients with this indication expansion than was possible with the initial approval as identification of the same has become simpler.
Along with the label expansion in EBC, the FDA also increased the scope of use of Verzenio in metastatic breast cancer (MBC), upon use in combination with an aromatase inhibitor, as initial endocrine-based therapy for the treatment of adult patients with HR+, HER2- advanced or MBC. The updated MBC indication now includes all patients, including pre/perimenopausal women, under expanded indication, subjective to use in combination with ovarian suppression.
According to popular statistics, more than 300,000 patients are suspected to be diagnosed with breast cancer in the United States in 2023, 90% of which are expected to be detected at an early stage. Approximately 70% of all breast cancer cases are the HR+, HER2- subtype, most of them advancing to incurable metastatic disease.
There is, however, significant competition in the market from other pharma bigwigs like Pfizer, Inc. (PFE - Free Report) and Novartis AG (NVS - Free Report) , with their breast cancer drugs, following the same mechanism of action. Pfizer’s Ibrance (palbociclib), in combination with Letrozole, was first approved by the FDA in February 2015, for the treatment of postmenopausal women with estrogen receptor-positive (ER+), HER2- MBC.
Verzenio already competes with Ibrance for the treatment of MBC, the latter having been approved for several expanded indications of MBC. In October 2020, Pfizer announced the failure to meet the primary endpoint in a label-expanding PENELOPE-B study of Ibrance for the treatment of EBC. Novartis’ Kisqali (ribociclib, LEE011), in combination with any aromatase inhibitor, was first approved by the FDA in March 2017, for the treatment of postmenopausal women with HR+, HER2- MBC. Novartis has announced several label expansions of Kisqali since its launch and accounts for an important driver of Novartis’ product revenues.