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.
Biosimilars provide lower-cost alternatives to biologic therapies. While not identical to the original drug, they must meet FDA standards to prove they are as safe and effective as the reference products.
The FDA has approved Inlexzo (gemcitabine intravesical system) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The product is packaged with a urinary catheter and stylet for insertion into the bladder.
The approval was based on cohort 2 of the SunRISe-1 trial, which enrolled 83 patients. Participants received Inlexzo every three weeks for six months, then every 12 weeks for up to 18 months. The treatment achieved a complete response rate of 82%, with 51% of those responses lasting at least one year.
Inlexzo delivers 225 mg of gemcitabine directly into the bladder. Each insertion remains in place for three weeks before removal, with treatment continuing on the outlined schedule until recurrence, progression or unacceptable side effects.
The FDA has approved Bildyos (denosumab-nxxp) injection 60 mg/mL as a biosimilar to Prolia (denosumab) and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 mL as a biosimilar to Xgeva (denosumab). Both are cleared for all indications of their reference products, according to a release from Henlius.
These approvals were based on data showing Bildyos and Bilprevda are highly similar to Prolia and Xgeva with no clinically meaningful differences in safety, quality or effectiveness.
Bildyos, a RANK ligand (RANKL) inhibitor, is used for osteoporosis in postmenopausal women and men at high risk of fracture, glucocorticoid-induced osteoporosis, bone loss in men on androgen deprivation therapy for prostate cancer, and bone loss in women receiving aromatase inhibitor therapy for breast cancer.
References
- “FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection,” by the U.S. Food and Drug Administration. News release; Sept. 19, 2025.
- “Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya and Aukelso, Denosumab Biosimilars,” by Biocon Biologics Ltd. (BBL). News release; Sept. 17, 2025.
- “FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer,” FDA; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer?check_logged_in=1
- “US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively,” Henlius. News Release. Sep. 2.
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