Eli Lilly Receives FDA Approval for Combination Breast Cancer Therapy
Eli Lilly's oral selective estrogen receptor degrader (SERD) imlunestrant (Inluriyo) has secured a second FDA approval, this time for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio), another drug from Lilly. This combination therapy is approved for ER-positive, HER2-negative breast cancer patients with ESR1 mutations whose disease has progressed after at least one line of endocrine therapy. The approval follows results from the phase 3 EMBER-3 trial, which demonstrated that the combination therapy doubled the median progression-free survival (PFS) to 11 months, compared to five and a half months for Inluriyo alone. According to Jacob Van Naarden, executive vice president and president of Lilly Oncology, this full approval expands the capabilities of Inluriyo in combination with Verzenio, offering a regimen with confirmed benefits that aligns with the clinical practice of changing therapy upon clinical progression. The all-oral combination targets two distinct drivers of tumor growth: on...