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.

DOWNLOAD THE PDF

Table of Contents

YOU MAY BE INTERESTED IN

Podcast

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woes
Directors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Candace S. Johnson leads America’s oldest cancer research center and Jonathan W. Friedberg leads the newest NCI-designated center. Their catchment areas are contiguous, their faculty and staff members collaborate often, and together their institutions embody the culture of NCI-designated cancer centers.

June 13, 2025

Vol.51 No.23

By Paul Goldberg

Capitol Hill

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheaval
Susan Collins: Trump’s 40% cut is “so disturbing”

In a 96-minute hearing in front of the Senate Appropriations Committee on the Trump administration’s budget, senators slammed NIH Director Jay Bhattacharya for not taking responsibility for the funding cuts to research and upheaval at NIH.

June 13, 2025

Vol.51 No.23

By Claire Marie Porter

Regulatory News

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

In the first meeting of the National Cancer Advisory Board since the inauguration of President Donald Trump, NCI Principal Deputy Director Douglas R. Lowy addressed many of the burning questions the oncology field has for the institute. On indirect costs: NCI will continue to use previously negotiated and approved indirect cost rates, with the exception...

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosis
Observational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms

Cannabis use disorder is associated with a dramatically increased odds of death within five years of diagnosis in people with colorectal cancer, a recent observational study found.

June 13, 2025

Vol.51 No.23

By Jacquelyn Cobb

Insights from ASCO 2025: Real-world evidence drives clinical decision-making

City of Hope researchers presented compelling real-world evidence and novel combination therapies at the 2025 ASCO Annual Meeting, with findings that could reshape treatment approaches for breast, colorectal, renal, and prostate cancers.

The Cancer Letter receives nine journalism, design awards

The Cancer Letter staff were finalists for nine 2025 Dateline Awards from the Washington, D.C. Chapter of the Society of Professional Journalists—seven for journalism; two for design—and won first place for four. The Cancer Letter’s entries recognized by SPJ include investigative journalism, series, breaking news, features, photojournalism, commentary, illustration, and front page design. This is...

June 13, 2025

Vol.51 No.23

By Katie Goldberg

FDA Grants Breakthrough Therapy Designation to LEE011 in Metastatic Breast Cancer

YOU MAY BE INTERESTED IN

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woes
Directors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheaval
Susan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosis
Observational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms

Insights from ASCO 2025: Real-world evidence drives clinical decision-making

The Cancer Letter receives nine journalism, design awards

Renew today!

Subscriber content

Never miss an issue!

Login

FDA Grants Breakthrough Therapy Designation to LEE011 in Metastatic Breast Cancer

YOU MAY BE INTERESTED IN

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woesDirectors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheavalSusan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosisObservational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms

Insights from ASCO 2025: Real-world evidence drives clinical decision-making

The Cancer Letter receives nine journalism, design awards

Never miss an issue!

Login

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woes
Directors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheaval
Susan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosis
Observational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms