Inavolisib

PredicineCARE™ enabled accurate identification of PIK3CA-mutated metastatic breast cancer patients in China, contributing to FDA approval of Inavolisib. The PredicineCARE™ liquid biopsy assay demonstrated a 98.7% success rate and 5-day turnaround time, supporting targeted therapy like Itovebi.

FY 2025 appropriations negotiations are on hold due to the general election; NIH funding remains a focus for the medical research community. The FDA's Oncologic Drugs Advisory Committee discussed PD-L1 expression as a biomarker for anti-PD-1 therapies, potentially leading to changes in drug labeling. An FDA-AACR workshop on DPD deficiency testing before chemotherapy with fluoropyrimidines is scheduled for January 16, 2025. Representatives Wasserman Schultz and DeGette urged the FDA to finalize e-cigarette PMTA reviews. The FDA approved five oncology drugs and new indications between September 21 and October 25, 2024.

Inavolisib plus fulvestrant and palbociclib significantly improved progression-free survival (PFS) in HR+, HER2-, PIK3CA-mutated breast cancer patients, reducing progression risk by 57% compared to palbociclib alone (PFS 15.0 vs 7.3 months, HR 0.43). FDA approved inavolisib regimen in October 2024, supported by INAVO120 data.

The INAVO120 trial showed a three-drug combo (inavolisib, palbociclib, and fulvestrant) delayed advanced breast cancer progression by 15 months, compared to 7.3 months with palbociclib and fulvestrant alone. The new therapy has been FDA-approved and aims to become the standard of care.

October 2024 saw significant FDA actions in oncology, including priority reviews for T-DXd in HER2-low/ultra-low breast cancer, acalabrutinib for frontline mantle cell lymphoma, and approvals for nivolumab plus chemotherapy in operable NSCLC, Cologuard Plus for CRC screening, and zolbetuximab for HER2-negative gastric cancer. Other notable actions included fast track designations, orphan drug designations, and expanded approvals for various cancer treatments.

FDA approved several cancer therapies in October, including Opdivo for non-small cell lung cancer, Itovebi for advanced breast cancer, Vyloy for HER2-negative gastric or GEJ adenocarcinoma, Jylamvo for children with acute lymphoblastic leukemia, and Scemblix for newly diagnosed chronic myeloid leukemia.

FDA approved inavolisib plus palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer, showing 58% response rate vs 25% with placebo, and median duration of response of 18.4 months vs 9.6 months.

A drug combo of palbociclib, inavolisib, and fulvestrant could double breast cancer patients' time without disease progression, showing 15 months vs. 7.3 months for placebo.

A three-drug therapy for advanced breast cancer, including inavolisib, palbociclib, and fulvestrant, delays disease progression by 15 months, compared to 7.3 months with palbociclib and fulvestrant alone, according to the INAVO120 study. The new combination has been FDA-approved and aims to become the standard of care for HR+, HER2- breast cancer.

A new three-drug combination therapy, including inavolisib, palbociclib, and fulvestrant, doubles progression-free survival in advanced breast cancer, delaying disease progression by 15 months compared to 7.3 months with current NHS-approved drugs. The INAVO120 study, led by Professor Nicholas Turner, demonstrated the therapy's potential for PIK3CA-mutated HR+, HER2- breast cancer, leading to FDA approval and hope for it becoming the standard of care.