Ibrance is the brand name of palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. It is used in combination endocrine regimens such as aromatase inhibitors or fulvestrant. The FDA first approved Ibrance on February 3, 2015.
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
The SONIA trial found no overall survival benefit for first-line CDK4/6 inhibitors versus second-line use in advanced HR+/HER2- breast cancer. Median survival was 47.9 vs 48.1 months, though post hoc analysis suggested benefit in premenopausal patients. First-line treatment was associated with more severe adverse events.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
Novartis will acquire Pikavation Therapeutics for up to $3 billion to gain its PI3Kα inhibitor programs, led by SNV4818 for metastatic breast cancer. The deal includes $2 billion upfront and up to $1 billion in milestones, with completion expected in first half 2026. SNV4818 is designed to selectively target mutated PI3Kα while sparing healthy cells.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
Researchers are developing personalized treatment approaches for rare and pediatric cancers using genetic profiling, AI-driven dosing, and 3D-printed medications to improve outcomes while reducing long-term toxicity.
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07492641 |
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease |
RECRUITING | PHASE3 |
| NCT07405164 |
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) |
RECRUITING | PHASE3 |
| NCT07347600 |
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer |
RECRUITING | |
| NCT07191977 |
Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07174336 |
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) |
RECRUITING | PHASE3 |
| NCT07123090 |
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma |
RECRUITING | PHASE2 |
| NCT06997029 |
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT06947811 |
A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations |
RECRUITING | PHASE1/PHASE2 |
| NCT06940349 |
Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT06895733 |
Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1) |
RECRUITING | PHASE1/PHASE2 |
