FDA Grants Breakthrough Therapy Designation to LEE011 in Metastatic Breast Cancer

FDA granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor.

The designation is based primarily on results of the phase III MONALEESA-2 trial in postmenopausal women who had received no prior therapy for their advanced disease. The trial met its primary endpoint of progression free survival at a pre-planned interim analysis. Results of this study will be presented at an upcoming medical congress and will form the basis of regulatory discussions in the US, Europe and other countries for use in this indication, according to the drug’s sponsor, Novartis.

LEE011 has been studied in non-clinical models and is currently being evaluated in combination with additional endocrine agents as part of the MONALEESA (Mammary ONcology Assessment of LEE011’s Efficacy and SAfety) clinical trial program. LEE011 is not approved for any indication in any market at this time. LEE011 was developed by Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals.

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FDA Grants Breakthrough Therapy Designation to LEE011 in Metastatic Breast Cancer

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FDA Grants Breakthrough Therapy Designation to LEE011 in Metastatic Breast Cancer

YOU MAY BE INTERESTED IN

Anthony Letai reflects on Year One as NCI Director: “The NCI is in business”

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer PanelThe cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

ASCO Genitourinary Cancers Symposium: Pioneering breakthroughs, optimizing patient outcomes

Never miss an issue!

Login

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer Panel
The cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”