The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
Recent studies and expert discussions highlight using ctDNA testing to guide surgery decisions for older ER-positive breast cancer patients and integrating FAST-Forward and PRIME II trial data to personalize radiation therapy and sequence with ADCs like T-DXd.
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.
Proteolysis-targeting chimeras (PROTACs) are advancing from experimental to clinical-stage cancer therapies, with first candidates entering Phase III trials. The technology degrades target proteins rather than blocking them, offering new options for previously undruggable targets.
Roche's experimental breast cancer pill giredestrant combined with a CDK4/6 inhibitor failed to meet its primary endpoint in a Phase III trial for first-line treatment of ER-positive, HER2-negative advanced breast cancer, marking a setback for the drugmaker's next-generation hormone therapy program.
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.
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
