Novartis Kisqali® (Ribociclib, LEE011) Receives FDA Approval as First-Line Treatment for HR+/HER2- Metastatic Breast Cancer in Combination with Any Aromatase Inhibitor

Excerpt:

“The US Food and Drug Administration (FDA) has approved Kisqali®(ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

“Kisqali is a CDK4/6 inhibitor approved based on a first-line Phase III trial that met its primary endpoint early, demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis. Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs.”

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Continuous Low-Dose Ribociclib Active in Advanced Breast Cancer Causes Less Neutropenia

Excerpt:

“Continuous low-dose ribociclib shows preliminary activity, and has an acceptable safety profile as an alternative to intermittent ribociclib dosing when combined with fulvestrant in the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

“A phase Ib study, presented at the 2016 San Antonio Breast Cancer Symposium, demonstrated a confirmed partial response (PR) of 13.3% in the continuous ribociclib arm, compared with 23.1% in the intermittent ribociclib arm, but a lower rate of high-grade neutropenia in patients receiving continuous dosing of ribociclib.”

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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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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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ASCO 2014: Highlights for People Dealing with Melanoma


Every year, new cancer treatment insights are shared at the American Society of Clinical Oncology (ASCO) Annual Meeting. Here are some of the most notable recent developments in melanoma treatment, gleaned from researchers’ presentations at ASCO last month: Continue reading…


Two Array-Invented MEK Inhibitors Showcased At ASCO

“Two Array BioPharma-invented MEK inhibitors, binimetinib (MEK162) and selumetinib, were showcased at the 50th annual meeting of the American Society of Clinical Oncology (ASCO).  At the meeting, preliminary data for the combination of binimetinib and CDK4/6 inhibitor LEE011 (discovered by Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals) from a Phase 1b/2 dose-escalation study conducted by Novartis in NRAS-mutant melanoma indicates the combination demonstrated an acceptable safety profile for most patients with promising preliminary antitumor activity.  Additionally, preliminary data for selumetinib showed favorable clinical activity in pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs).”

Editor’s note: This article discusses a melanoma treatment that combines two durgs: binimetinib (aka MEK162) and selumetinib. A clinical trial recently found that the combo shows promise for melanoma patients whose tumors have mutations in the NRAS gene, as detected by molecular testing. Binimetinib is also being tested as a potential treatment for patients whose tumors have mutations in the BRAF gene.


Melanoma: A 2013 ‘Progress Report’


The past year saw some remarkable advances in melanoma clinical research and treatment. This feature explores the most notable melanoma news of 2013: Continue reading…