In September 2025, the U.S. Food and Drug Administration (FDA) approved several new cancer therapies and supportive care options, including treatments for breast, bladder and prostate cancers, as well as new biosimilars and a subcutaneous version of an existing immunotherapy.
The FDA has approved Inluriyo (imlunestrant, 200 milligram tablets) for adults with estrogen receptor (ER)-positive and HER2-negative breast cancer, as per the FDA.
This oral estrogen receptor antagonist is indicated for patients whose cancer has an ESR1 mutation and has advanced or spread (metastatic breast cancer). It is also intended for individuals whose disease progressed after at least one prior line of endocrine therapy.
Glossary
Progression-free survival (PFS): time during and after treatment that a patient lives without cancer growing or spreading.
Overall survival (OS): time from treatment start or diagnosis until death from any cause.
Overall response rate (ORR): percentage of patients whose cancer shrinks or disappears after treatment.
Complete response (CR): disappearance of all signs of cancer from treatment.
Median progression-free survival (median PFS): the middle value of time patients lived without cancer worsening, meaning half had longer PFS and half had shorter.
Duration of response (DOR): length of time a treatment keeps cancer under control after it first responds.
The FDA approval was supported by results from the EMBER-3 trial, which included 256 patients with ESR1-mutated metastatic breast cancer. Inluriyo reduced the risk of disease progression or death by 38% compared with standard endocrine therapy. Median progression-free survival was 5.5 months with Inluriyo versus 3.8 months with standard therapy, showing a significant benefit over Faslodex (fulvestrant) and Aromasin (exemestane).
The FDA approved Keytruda Qlex (pembrolizumab and hyaluronidase alfa-pmph) for subcutaneous use in adults and children 12 years and older with solid tumor indications already approved for the intravenous (IV) version of Keytruda, according to a regulatory announcement.
The approval was based on Study MK-3475A-D77, which assessed the safety and efficacy of this new formulation. The study enrolled 377 patients with newly diagnosed metastatic non-small cell lung cancer (NSCLC) without certain mutations such as EGFR, ALK or ROS1.
Results showed Keytruda Qlex was comparable to the IV form, meaning drug levels in the body were similar following subcutaneous injection. In terms of treatment outcomes, the overall response rate (ORR) was 45% with Keytruda Qlex and 42% with the IV version. Progression-free survival (PFS) and overall survival (OS) were also nearly identical between the two groups.
The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), biosimilars of Prolia and Xgeva. Bosaya is indicated for men at high risk of fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and for women at high risk of fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Bosaya will be available as a prefilled syringe for subcutaneous injection, while Aukelso will be offered as a single-dose vial for subcutaneous injection.
