Onco-Summaries: Daily Oncology Updates at a Glance
Updated: Sep 22
18/09/2026
US FDA approves Inluriyo + Verzenio for ESR1-Mutated ER+/HER2− Metastatic Breast Cancer (Ref)
Eli Lilly announced that the U.S. FDA has granted full approval to Inluriyo (imlunestrant; estrogen receptor antagonist) + Verzenio (abemaciclib; CDK4/6 inhibitor) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following endocrine therapy
The full FDA approval is based on the results of the Phase 3 EMBER-3 trial in patients with MBC whose tumors harbor an ESR1 mutation
The combination demonstrated a median progression-free survival (PFS) of 11.1 months vs 5.5 months with imlunestrant alone, corresponding to a 47% reduction in the risk of disease progression or death (HR=0.53)
Safety findings were consistent with the known profiles of both agents, with most adverse events reported as Grade 1 or 2
This marks the second FDA approval for Inluriyo following its prior approval as monotherapy for ESR1-mutated metastatic breast cancer
Japan Approves Keytruda SC, Expanding Global Commercialization of Alteogen's ALT-B4 Platform (Ref)
Japan has approved the subcutaneous (SC) formulation of Keytruda (pembrolizumab), representing major regulatory milestone for Alteogen's ALT-B4 (Hybrozyme®) platform and further expanding the global commercialization footprint of Keytruda SC
Japan approved Keytruda SC (marketed locally as Kijecht), extending availability of the product in a major oncology market
The SC formulation utilizes Alteogen's ALT-B4 (vera hyaluronidase alfa) technology to enable rapid subcutaneous administration of pembrolizumab.
Keytruda SC reduces treatment administration time from a conventional IV infusion to a short SC injection, offering potential workflow and patient convenience benefits
The approval was supported by results from the international Phase 3 joint trial “MK-3475A-D77", demonstrating noninferiority versus intravenous Keytruda, with no new safety signals identified
Amneal Announces US FDA Approval and Launch of Lanreotide Injection (Ref)
Amneal Pharmaceuticals announced that the US FDA has approved and the company has launched its generic lanreotide (somatostatin analog) injection (120 mg/0.5 mL prefilled syringe), referencing SOMATULINE® Depot
The approval expands Amneal's complex injectable portfolio and strengthens its presence in specialty and oncology-related therapeutic markets
Lanreotide injection was granted Competitive Generic Therapy (CGT) designation by the FDA
The therapy is approved for the treatment of acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome
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