Peptide News Digest

#Cdk4-6-Inhibitor

2 stories

Regulatory · View digest

FDA Approves Eli Lilly Inluriyo (Imlunestrant, Oral SERD) + Verzenio (Abemaciclib, CDK4/6 Inhibitor) Combination for ER+/HER2−/ESR1-Mutated Advanced or Metastatic Breast Cancer After Prior Endocrine Therapy; Median PFS 11.1 Months vs 5.5 Months on Monotherapy

The FDA approved Friday September 18, 2026 Eli Lilly's (NYSE: LLY) Inluriyo (imlunestrant, oral next-generation selective estrogen receptor degrader / SERD) in combination with Verzenio (abemaciclib, oral CDK4/6 inhibitor) for adults with estrogen-receptor-positive (ER+), HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one prior line of endocrine therapy. ESR1 mutations are detected via the FDA-authorized Guardant360 CDx companion diagnostic (Guardant Health, NASDAQ: GH). Patients on the combination had median progression-free survival of 11.1 months versus 5.5 months on Inluriyo monotherapy — an approximately 2× improvement. This is Inluriyo's second FDA approval within a year after its September 2025 monotherapy approval in the same population and is the first FDA-approved oral-SERD + CDK4/6 inhibitor combination in this setting. The approval strengthens Lilly's breast-cancer franchise anchored by Verzenio ($6.3B 2025 global sales) and expands the addressable population for both agents.

Regulatory · View digest

FDA Grants Accelerated Approval to AstraZeneca Etcamah (Camizestrant) Plus CDK4/6 Inhibitor for ESR1-Mutated HR+ HER2- Advanced Breast Cancer; Guardant360 CDx Approved as Companion Diagnostic

AstraZeneca (NASDAQ: AZN) announced Friday September 4, 2026 that the FDA granted accelerated approval to Etcamah (camizestrant, an oral selective estrogen receptor degrader) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone-receptor-positive HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor plus CDK4/6 inhibitor therapy. FDA also approved the Guardant360 CDx blood-based next-generation sequencing assay as a companion diagnostic to identify ESR1-mutant patients. Approval was based on the Phase 3 SERENA-6 trial that documented a 56% reduction in disease progression or death versus continued standard-of-care aromatase inhibitor plus CDK4/6 inhibitor treatment in the ESR1-mutated subgroup. SERENA-6 was presented at ASCO 2026 and simultaneously published in the New England Journal of Medicine. Etcamah becomes the first oral SERD approved for the switch-at-emergence-of-ESR1 setting, replacing the fulvestrant intramuscular injection historically used post-progression. AstraZeneca is positioning Etcamah alongside Trodelvy plus Datroway as anchors of the expanded breast-cancer franchise.