Oct. 14, 2024 – A brand new breast cancer drug has received fast-track federal approval permit After a clinical trial showed it could greater than double the time before one common style of breast cancer the reoccurrence becomes worse.
The FDA approved Itovebi for individuals with hormone-sensitive breast cancer that comes back during or after taking endocrine therapy, resembling the drug tamoxifen. Itovebi is simply approved for individuals who have a genetic mutation called PIK3CA and whose cancer type is HER2 negative. (HER2 refers to a protein that may affect cancer growth.)
Along with approving the brand new drug, the FDA also approved a genetic test called FoundationOne Liquid CDx as an choice to discover individuals with the PIK3CA mutation. The mutation occurs in 40% of hormone-sensitive and HER2-negative breast cancers.
One of the researchers within the Itovebi clinical trial called the drug “a new standard in the treatment of PIK3CA-mutant breast cancer.”
“The PI3K pathway plays a critical role in disease progression and has been difficult to target,” Komal Jhaveri, MD, breast oncologist and clinical director of drug development at Memorial Sloan Kettering Cancer Center, said in a Press release from the drug manufacturer Genentech.
The generic name of Itovebi is inavolisib and it’s approved to be used alongside already approved treatments for any such breast cancer reoccurrence, the drugs Ibrance and Faslodex. Their generic names are palbociclib and fulvestrant, respectively.
In the clinical trial of 325 people, those that took the three drugs took a mean of 15 months before their cancer spread or died from the disease (a measure often known as progression-free survival). Study participants who took only Ibrance and Faslodex had a mean of just over seven months of progression-free survival, the FDA said in its approval. The agency noted that complete data shouldn’t be yet available, but early numbers suggest that adding Itovebi could ultimately help people live longer.
Itovebi is taken as a each day tablet. The FDA approval outlined that essentially the most common unwanted side effects affected 20% or fewer of study participants and included abnormalities in laboratory tests, mouth or lip sores, diarrhea, fatigue, nausea, rash, decreased appetite, COVID-19 infection and headache . The drug's label also warns in regards to the risk of hyperglycemia, or high blood sugar levels.