VIDEO: Recent approvals in breast cancer

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Over the last year and a half, we've seen a few drugs that have been approved, particularly in the hormone receptor positive breast cancer space. One of the most recent approvals was a targeted therapy against the PI3 kinase pathway. So it's capivasertib (Truqap, AstraZeneca), which was approved towards the end of 2023 in combination with fulvestrant (Faslodex, AstraZeneca). So this is a new option for patients with alterations in this pathway. Prior to that, we had the drug called alpelisib (BYL719, Novartis), which had been approved before in this space. However, that drug was approved particularly for patients that had tumors with PIK3 CA mutations, capivasterbib in addition to that, it's an option for patients that have AKT1 alterations and also P10 alter tumors, so it expand a bit the pool of patients that would be eligible for that treatment.

In addition to that, we also received an update in the FDA approval for adjuvant abemaciclib (Verzenio, Eli Lilly). So this is a drug that had been approved previously for patients with high-risk, early-stage breast cancer that had four or more axillary lymph nodes, or who had one to three axillary lymph nodes with a large tumor greater than five centimeters or a grade three tumor. But the previous indication required, in addition, having a KI 67 of 20% or greater. Around March/April of 2023, the FDA removed that requirement for the KI 67, so it expands the population of patients that could be eligible for that drug.

And then the two other that have been in the last year and a half are sacituzumab govitecan (Trodelvy, Gilead) and elacestrant (Orserdu, Stemline Therapeutics). So sacituzumab govitecan received an expanded indication for patients with metastatic hormone receptor positive breast cancer. This drug had been approved before for patients with triple negative breast cancer, but now based on the TROPiCS-02 trial, the label was expanded to include also metastatic hormone receptor positive patients that had experienced tumor progression after CDK4/6 inhibitors, endocrine therapy, and at least two prior lines of chemotherapy.

And finally, elacestrant, which is one of our new oral SERDs, you know, that was also approved for patients that have tumors with ESR1 mutations. So these four drug have been the most recent approvals. Again, a very active space for the hormone receptor positive breast cancer research field, particularly over the last year and a half.