Home · Health · Sep 21 archive
FDA Approves Lilly's Breast Cancer Combo
Developing
In Short: The FDA has approved Eli Lilly's imlunestrant in combination with abemaciclib for certain breast cancer patients.
The FDA has approved the selective estrogen receptor degrader (SERD) imlunestrant (Inluriyo, Eli Lilly) in combination with CDK4/6 inhibitor abemaciclib (Verzenio, Eli Lilly) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
The approval came just two weeks after the FDA gave accelerated approval to a rival combination from AstraZeneca, which includes the SERD camizestrant (Etcamah) plus any of three CDK4/6 blockers — abemaciclib, palbociclib, or ribociclib.
AstraZeneca had argued that its approval would allow clinicians to make a therapeutic switch early, before the cancer becomes harder to treat. However, the FDA's Oncologic Drugs Advisory Committee had voted 6-3 against approval, citing a lack of evidence that clinical outcomes improve if an AI is switched to a SERD before disease progression.
The camizestrant approval marked the first time the FDA OK'd a change in cancer treatment based on ctDNA testing instead of disease progression.
The approval of imlunestrant and abemaciclib offers another option for patients with specific types of breast cancer who have progressed after initial endocrine therapy.
What this adds
The approval of imlunestrant and abemaciclib comes amid ongoing debates about the efficacy and timing of therapeutic switches in breast cancer treatment.
Background
White House Chief of Staff Susie Wiles has announced she is cancer-free, six months after her early-stage breast cancer diagnosis.
Scholar Rock's Isembyld, the first drug to target spinal muscle atrophy muscle loss, has received FDA approval, raising hopes for improved mobility in patients.
What's still developing
- Nothing material beyond the confirmed record.