FDA Approves New Combination Therapy for Advanced Breast Cancer

In a significant development for breast cancer treatment, the U.S. Food and Drug Administration (FDA) has approved a new combination therapy for certain types of advanced breast cancer. On October 10, 2024, the FDA gave the green light to inavolisib (brand name Itovebi), manufactured by Genentech, Inc., to be used in combination with palbociclib and fulvestrant[1]. This approval is specifically for adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer[1]. The treatment is indicated for patients whose cancer has recurred after or during adjuvant endocrine therapy, as detected by an FDA-approved test[1].

The approval was based on the results of the INAVO120 trial, which involved 325 patients with the specified type of breast cancer[1]. The study showed significant improvements in progression-free survival for patients receiving the inavolisib combination compared to those on placebo. The median progression-free survival was 15.0 months for the inavolisib group versus 7.3 months for the placebo group[1]. Additionally, the objective response rate was notably higher in the inavolisib arm at 58%, compared to 25% in the placebo arm[1].

While the treatment shows promising results, it’s important to note that it comes with side effects. Common adverse reactions included decreased blood cell counts, increased fasting glucose, stomatitis, diarrhea, fatigue, and various other symptoms[1]. The recommended dose for inavolisib is 9 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity occurs[1].

This approval marks a significant step forward in personalized medicine for breast cancer treatment. The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic to identify suitable patients for this therapy[1]. The review process for this drug was expedited under the FDA’s Project Orbis initiative, which allows for concurrent submission and review of oncology drugs among international partners[1]. The FDA collaborated with regulatory agencies in Australia, Canada, and Switzerland for this review[1].

Healthcare professionals are encouraged to report any serious adverse events associated with this new treatment to the FDA’s MedWatch Reporting System. This approval represents a new option for patients with this specific type of advanced breast cancer, potentially offering improved outcomes and quality of life.

Quellen:
[1] fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive
[2] FDA approves inavolisib with palbociclib and fulvestrant for endocrine https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive