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Recent FDA Approval of Ribociclib as Upfront Therapy

Kimberly L. Blackwell, MD, Duke University School of Medicine
Published: Monday, May 22, 2017



Transcript:

Kimberly L. Blackwell, MD:
Ribociclib was recently approved by the Food and Drug Administration here in the United States in combination with a type-2 aromatase inhibitor known as letrozole. We’re all familiar with letrozole, and the approval will combine ribociclib in what’s called the first-line metastatic setting. These are women who have not received therapy for their metastatic or recurrent hormone-sensitive breast cancer. The approval was really based on a significant increase in time to progression above and beyond using letrozole alone. So, its indication will be in combination with letrozole for the first-line treatment of hormone-sensitive metastatic breast cancer.

For me, the ribociclib approval is not just exciting because we have a new drug that we can now offer patients facing hormone-sensitive metastatic breast cancer, but also, in many ways, it confirmed that the CDK pathway is so important to inhibit—that really adds to the benefits of endocrine therapy. Very similar to what we saw with the initial palbociclib studies, ribociclib also significantly improves progression-free survival. The hazard ratio is 0.55, which is really the same benefit we see with the addition—and just in terms of hazard ratio—of trastuzumab to chemotherapy. So, this is not a small benefit. You don’t have to look and ask, “Is it a couple of weeks?” We’re talking about several months of improvement in progression-free survival.

For the patient, this means going from taking 1 pill a day to taking 2 pills a day—well, a collection of pills a day, depending on what dose they’re on. Although it does involve more frequent laboratory monitoring. The side effect profile, I would argue, is very similar—if not better—than adding many of the other targeted agents we use for the treatment of metastatic breast cancer.

Transcript Edited for Clarity
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Transcript:

Kimberly L. Blackwell, MD:
Ribociclib was recently approved by the Food and Drug Administration here in the United States in combination with a type-2 aromatase inhibitor known as letrozole. We’re all familiar with letrozole, and the approval will combine ribociclib in what’s called the first-line metastatic setting. These are women who have not received therapy for their metastatic or recurrent hormone-sensitive breast cancer. The approval was really based on a significant increase in time to progression above and beyond using letrozole alone. So, its indication will be in combination with letrozole for the first-line treatment of hormone-sensitive metastatic breast cancer.

For me, the ribociclib approval is not just exciting because we have a new drug that we can now offer patients facing hormone-sensitive metastatic breast cancer, but also, in many ways, it confirmed that the CDK pathway is so important to inhibit—that really adds to the benefits of endocrine therapy. Very similar to what we saw with the initial palbociclib studies, ribociclib also significantly improves progression-free survival. The hazard ratio is 0.55, which is really the same benefit we see with the addition—and just in terms of hazard ratio—of trastuzumab to chemotherapy. So, this is not a small benefit. You don’t have to look and ask, “Is it a couple of weeks?” We’re talking about several months of improvement in progression-free survival.

For the patient, this means going from taking 1 pill a day to taking 2 pills a day—well, a collection of pills a day, depending on what dose they’re on. Although it does involve more frequent laboratory monitoring. The side effect profile, I would argue, is very similar—if not better—than adding many of the other targeted agents we use for the treatment of metastatic breast cancer.

Transcript Edited for Clarity
View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: 16th Annual International Congress on the Future of Breast Cancer®Sep 29, 20182.0
School of Breast Oncology®: Mid-Year Video Update OnlineSep 30, 20182.0
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