Part 1: Takeaways from SABCS 2019
Editor's Note: This is Part 1 of a series of articles from one of our advocates who attended the 2019 San Antonio Breast Cancer Symposium. Additional articles in this series will be forthcoming.
One of the most anticipated parts of attending the San Antonio Breast Cancer Symposium (SABCS) is hearing about the new medication that has been or will be approved by the FDA. These drugs usually represent the biggest breakthroughs each year and while the doctors often already know about them, it's pretty big news for those of us who attend as patient advocates. 2019 was my second time attending this largest gathering of breast cancer researchers in the world and it's definitely on my list for 2020.
But, onto the medication that we learned about this year in San Antonio, which I'll describe in chronological order from when they were approved by the FDA throughout the year in 2019.
List of newly approved medication
HER2+ breast cancer
First of all, in Feb. 2019, the FDA approved the subcutaneous injection consisting of Herceptin (Trastuzumab) and Hyaluronidase-oysk (Herceptin Hylecta) for the treatment of HER2+ breast cancer. In one of the two trials that led to the approval, pathological complete response (pCR) was observed in 118 patients (45.4%) on the Herceptin Hylecta arm and in 107 patients (40.7%) receiving intravenous trastuzumab (95% CI for the difference in pCR: -4.0; 13.4). Great news for those people who are HER2+.
Triple-negative metastatic breast cancer
Secondly, in March 2019, the FDA granted accelerated approval for Tecentriq (Atezolizumab) in combination with Abraxane (nab-paclitaxel) for the first-line treatment of Triple-Negative Breast Cancer (TNBC) Metastatic Breast Cancer (MBC) patients whose tumors are PD-L1 positive.
This is pretty exciting since it's the first FDA-approved immunotherapy medication for MBC.
Hormone receptor-positive, HER2 negative metastatic breast cancer
Third, in April 2019, the FDA expanded the approval of Ibrance (Palbociclib) with either an Aromatase Inhibitor (Letrozole, Arimidex, Aromasin) or Faslodex (Fulvestrant) to include men with hormone receptor-positive, HER2 negative MBC. Men do make up a smaller percentage of those of us with MBC than women and it's still a bit baffling to me why we don't have arms for men in all the trials, but that's a question for another time. For now, men now have officially approved access to the first approved CDK4/6 inhibitor.
Hormone receptor-positive, HER2 negative metastatic with a PIK3CA mutation
Fourth, in May 2019, the FDA approved Piqray (Alpelisib), on an accelerated status, an oral PIK3 inhibitor, in combination Faslodex for the treatment of postmenopausal women (as well as men) with hormone receptor-positive, HER2 negative MBC with a PIK3CA mutation who had progressed on or after an endocrine-based treatment regimen. This is my second-line treatment after I had progression while on Ibrance (Palbociclib) in August of 2019. I'm pretty excited that it was available at the right time for me. Looking forward to seeing the data that comes from Novartis once they release it as those of us who are on it are paving the way for patients in the future.
Biosimilar intravenous drugs
Fifth, during the first half of 2019, the FDA approved three biosimilar intravenous drugs to Herceptin (Trastuzumab): 1) SB3 (Ontruzant; trastuzumab-dttb); 2) Trazimera (trastuzumab-qyyp); and 3) Kanjinti (trastuzumab-anns). It is my understanding that a biosimilar is a biologic medical product highly similar to another already approved biological medicine. While, biosimilars are approved according to the same standards of quality, safety and efficacy that apply to all biological medicines, I've heard of some people having reactions to the biosimilars when they hadn't had a reaction to Herceptin. This topic will be hotly discussed, I'm sure, as time goes on, but good news for those who struggle to pay for Herceptin.
Unresectable or metastatic HER2 positive breast cancer
Sixth and finally, immediately following SABCS 2019, the FDA granted accelerated approval to Enhertu (fam-Trastuzumab Deruxtecan- nxki, also known as DS-8201) for patients with unresectable or metastatic HER2 positive breast cancer who had received 2 or more prior anti–HER2-based medication(s). I've already heard of several people who have been prescribed Enhertu and I'm sure we will start seeing information come out about this medication.
What to know when trying a new line of treatment
One note about taking medication that warranted expedited or accelerated approval is that the general medical community isn't as familiar. My doctor and I had selected Piqray as my second-line treatment, so I'd done a bit of research (as had my doctor) on how to manage side effects and what I might expect. Since the main side effect is hyperglycemia (high sugar levels), I also see an endocrinologist regularly. I was the first one at my cancer center to take Piqray and the first that any of my doctors had prescribed it to. This means there was a pretty steep learning curve, for all of us. Keep this in mind if you have an opportunity to take a medication in this way.
Were any of the other medications approved by the FDA in 2019 significant to you? Why or why not?
Were any of these medications a surprise or breakthrough for you?
What other trials or medication are you looking forward to being approved?
Have you updated your status on our site yet?