FDA Grants Ribociclib Priority Review for Frontline HR+/HER2

Excerpt:

“The FDA granted a priority review to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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FDA Gives Ribociclib Priority Review for Frontline HR+/HER2- Breast Cancer

Excerpt:

“The FDA has granted priority review designation to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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Study Finds Ribociclib Improves Progression-Free Survival for Women with Metastatic Breast Cancer

Excerpt:

“In a randomized, Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center, ribociclib, in combination with the aromatase inhibitor letrozole, dramatically improved progression-free survival (PFS) of post-menopausal women with hormone receptor-positive metastatic breast cancer, compared to the hormone therapy alone.

“The study found a 44 percent improvement in PFS with ribociclib, a CDK4/6 inhibitor, and letrozole as a front line therapy. Gabriel Hortobagyi, M.D., professor of Breast Medical Oncology, presented the findings at ESMO 2016 Congress, and is the corresponding author of the New England Journal of Medicine paper.”

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Encouraging Results For Ribociclib In Advanced Breast Cancer

Excerpt:

“At the European Society for Medical Oncology (ESMO) Congress this week, investigators presented data for a new and potentially important drug, ribociclib (Novartis). This oral medication is clearly active in hormone receptor-positive (ER+ or PR+) breast cancer. The findings of the MONALEESA trial were published in the NEJM.

“The main result is that for the most common form of advanced breast cancer, adding ribociclib to letrozole significantly improved progression-free survival (PFS), as compared to adding a placebo. After a year and a half (18 months) in this randomized, controlled clinical trial, PFS among women receiving ribociclib was 63.0%, vs. 42.2% in the placebo arm. That’s a big difference, when you consider that 99% of the patients on the study have stage 4, metastatic breast cancer.”

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US Breakthrough Status for Novartis' Breast Cancer Drug

Excerpt:

“Novartis’ experimental selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has picked up a Breakthrough Therapy designation in the US for the treatment of certain forms of breast cancer.

“The drug is being developed for use alongside letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

“The award indicates the US Food and Drug Administration’s belief that LEE011 could potentially offer an improvement over an available therapy on at least one clinically significant endpoint, and is designed to help speed up its regulatory pathway to ensure quicker access for patients.”

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Novartis Breast Cancer Drug Set to Take on Pfizer's Ibrance

Excerpt:

“A clinical trial testing an experimental breast cancer pill from Novartis has been stopped early because of good results, boosting the Swiss company’s efforts to build up its oncology business.

“The news puts Novartis on track to compete with a similar blockbuster product from Pfizer that is already on the market.

“Novartis said on Wednesday that testing of LEE011 in combination with letrozole in the late-stage study had been halted early after it met its goal of significantly extending the time patients lived without their disease progressing.

“LEE011, or ribociclib, belongs to the same drug class as Pfizer’s Ibrance. The Novartis product now looks set to be second to market in the category, ahead of Eli Lilly’s abemaciclib, according to Berenberg Bank analysts.”

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